Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Manufacturer's Recommendations: 1. Locate and segregate all batches of affected products within your institution. The product code and batch number can be found on the products or in the shipping boxes. 2. If you purchased this product directly from the company holding the registration, fill out the customer response form and send to the company via e-mail to faleconosco@baxter.com or via fax to (XX) 11 5635-0106 or to 0800 012 5522, informing the quantity present in your stock, even if there is no remaining stock in your facility. The prompt return of the customer response form will confirm receipt of the notification and will prevent you from receiving the notice several times. 3. Once this is done, the company will contact you to arrange for return and credit. 4. If you distribute this product to other institutions or departments within your institution, please send a copy of that document to them. 5. If you are a reseller, wholesaler, distributor or original equipment manufacturer (OEM) distributing any affected product to other institutions, please conduct the collection at the customer level that you distributed the affected products. Then inform the company according to the procedure described in step 2. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http://portal.anvisa.gov.br/notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 03/04/2018 - Date of notification notice to Anvisa: 05/10/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
The company is issuing a voluntary recall of product for some batches of exactamix transfer equipment. reports that the affected exactamix transfer kit lots were over-labeled with a blank label or label containing an expiration date. informs that, if the product is used after the expiration date, sterility can not be guaranteed.
Acción
Field Action, Code FA-2018-013, under the responsibility of the company Baxter Hospitalar. Gathering. Undoing.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Segregate the product under risk from your inventory, identifying it to avoid inadvertent use. Contact the dealer from whom you purchased the product to exchange the product. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 19/04/2018 - Date of notification notice to Anvisa: 05/10/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: (...) Art. 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...)
Causa
Product exhibiting a ph divergence and fluid retention, leading to a restriction of product performance and quality.
Acción
Field Action Code 001/2018 under the responsibility of the company America Medical Ltda. Gathering.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Make sure that the organization that serves your CT scanning system is aware of this potential risk and wear protective gloves when using the wheel rims on the cover until GE Healthcare can correct it. The company states that there is no risk to its patients or to its CT Operators / technicians, only to field engineers capable of performing internal equipment maintenance. It states that customers can continue to use their system while waiting for this fix. All affected systems will be inspected as part of this Field Action. The inspection will include verification of damage to the cable and proper routing of cables. Those systems that have damage to the cable will receive a replacement. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 04/26/2018 - Date of notification notice to Anvisa: 05/11/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
The registrant has identified that some ct scanning systems may have damaged cable, which may expose 120 vac to maintenance engineers working with the equipment. it states that this problem does not affect patients or operators outside the equipment. when the front cover of the gantry is removed for the maintenance of components within the gantry, platforms on the cap wheels are used to handle the cap. during the removal or replacement of the front cover, the stand may come in contact with the internal power cable and may damage the insulation of that cable. this may expose the conductor of the 120 vac power cord and electrify the wheel's deck on the cover, thereby introducing the risk of electric shock to maintenance personnel.
Acción
Field Action IMF Code 26859 under the responsibility of GE Healthcare do Brasil, Com. for Equipos Médico-Hospitalares Ltda. Field Correction. Parts / parts correction.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The company informs customers that in most cases, labs do not need to review past results or retest patients because cross-contamination and the generation of false positive results are usually rare and require the presence of a high titre sample in the battery tested. It states that if the samples were tested for the diagnosis of acute and self-limited conditions, there would be no benefit to the patient from a retrospective review of previous results or a retest. It reports that a review of previous results is relevant only in cases where the MagNA Pure 24 Pathogen (200 and / or 1000) protocols were used to extract nucleic acids for an assay of a chronic infectious disease (eg hepatitis C) and one change in outcome could affect treatment outcome. Reports that suspected false positive results that could potentially affect patient behavior should be retested according to local procedures using the MagNA Pure Instrument with the recently released Pathogen200 hp or Fast Pathogen 200 protocols or the External Lysis Pathogen 200 and 500 protocols or an alternative method. It states that since cross-contamination and the generation of false positive results are considered rare and require the presence of a high titre sample (unlikely frequency), until the updated Pathogen200 and Pathogen1000 protocols are available, users can: 1. Use the newly released Pathogen200 hp or Fast Pathogen 200 protocols or the External Lysis Pathogen 200 and 500 protocols, if available in your country; 2. Use an alternate method for testing purposes. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 04/13/2018 - Date of notification notice to Anvisa: 05/11/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
The company holding the registration informs that a risk of cross-contamination of samples for the pathogen200 protocol in the magna pure 24 system, reported by an external customer, has been identified. the internal investigation performed by the manufacturer confirmed the event reported by the client in the pathogen200 and pathogen1000 protocols. the company detected that cross-contamination of samples during the extraction of nucleic acids from pathogens can generate false-positive results or overestimated values. false positive or overestimated results can lead to unnecessary medical treatments or side effects with a likelihood that the company is remote from creating adverse health consequences. some pathogens such as hepatitis b (hbv) may be present in titers in excess of 10e9, and therefore even small contamination may result in erroneous results.
Acción
Field Action Code SBN-RMD-2018-001 under the responsibility of the company Roche Diagnóstica Brasil Ltda. Update of Pathogen200 and Pathogen1000 Protocols.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The manufacturer considers that there is no risk to patients who have been previously examined. The company said that the technical assistance organization will contact customers to arrange for corrective action, but it is possible to contact the technical assistance organization to schedule a more urgent appointment. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 04/26/2018 - Date of notification notice to Anvisa: 05/25/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
According to the company that owns the registry, there is a possibility that the large monitor will not show any image due to a technical problem. this may occur after the large monitor enters the power saving mode. the large monitor remains black without displaying any error message. the company said that x-rays are still possible. still, he reported that the problem occurs sporadically and only when the monitor returns from energy-saving mode. it does not occur during a procedure.
Acción
Field Actions Code AX075 / 17 / S (Customer Letter) & AX074 / 17 / S (Field Correction - Software Update) under the responsibility of Siemens Healthcare Diagnósticos Ltda.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The company that holds the registry recommends the following actions: 1. Inspect the inventory immediately to identify the existence of products subject to this recall; 2. After identification, segregate the units and report the problem to the relevant staff of the surgical or material management center; 3. Fill in the Commercial Response Form (FRC) (Annex 2), confirming receipt of the notice within three (3) business days. 4. Keep the communication in a visible place until all batches of products subject to recall have been returned to the company that holds the record. 5. Immediately return all batches of unused and recalled Scissors that are in your inventory until August 31, 2018. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA ) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http://portal.anvisa.gov.br/notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 09/05/2018 - Date of notification notice to Anvisa: 05/28/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
According to the company holding the registry, there are some devices contained in the aforementioned lots that were assembled with an internal component that can result in continuous or inadvertent activation of the device. informs that such a situation may cause inadvertent mechanical or thermal damage to the unintentional tissue if continuous or inadvertent activation occurs during surgery.
Acción
Field Action Code 1188346 under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Gathering. Undoing.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The company makes the following recommendations for managing the power supply of the HVAD Systems in the Customer Charter: • Reinforce the importance of always ensuring that TWO power sources (AC or DC adapter plus one battery OR two batteries) are connected to the entire (except when changing the power source). Reinforce best practice guidelines for managing power supplies when you sleep and wake up: - Go to sleep, connect a fully charged battery, and then plug in the AC adapter. - When getting up in the morning, be sure to connect two fully charged batteries. Instruct patients to report persistent and unexpected audible sounds to the VAD team for additional instructions. Refer to Appendix A of the Customer Charter: HVAD System with Controller 1.0 - Identifying Behaviors of Unexpected Power Source Change. Refer to Appendix B: HVAD System with Controller 2.0 - Identifying Behaviors of Unexpected Power Source Change. Report any unexpected events to your local Medtronic representative and file a complaint, including records of the normal processes. If unexpected behavior persists and is responsible for possible confusion or anxiety of the patient, consider instead replacing the suspected source of energy and returning it to Medtronic for analysis during the complaint handling process. If unexpected behavior continues after replacement of the suspected energy source, consider replacing the Controller - if the condition of the patient allows according to the clinical judgment. Refer to the HVAD System Instructions for Use for detailed guidelines on controller replacement performance. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 01/05/2018 - Date of notification notice to Anvisa: 05/08/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
The company informs about the possible transient interruption of the electrical connection of the power source of the hvad controller (battery, ac adapter or dc adapter) to the hvad controller that may result in an alteration of energy not intended for the secondary power supply and / or audible sounds unexpected ("beeps"). this interruption, which may occur while the power source remains physically connected, is due to the oxidation of the connection surfaces between a power supply connector and the power supply socket on the controller and usually lasts between 1 and 2 seconds. further, the company informs that unexpected beep may occur when the interruption resolves automatically and may cause confusion to the patient or caregiver, since the controller may show sufficient battery capacity or ac / dc connectivity at the time of audible sound. a critical battery alarm can also be briefly displayed due to this phenomenon.
Acción
Field Action Code FA817 under the responsibility of the company Medtronic Comercial Ltda. Communication to customers who purchased the product, describing the problem, how to identify it, how to use it, and how to report the problem. Upon being contacted by ANVISA, the company informed that it is developing a definitive solution to the problem, which will be announced as soon as it is finalized.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Patients receiving therapy with BBIA are in critical condition. Failure to start or stop suddenly may result in unsafe hemodynamic instability. Until the top protective cover is installed by the company, follow the instructions below when using the Cardiosave intra-aortic balloon pump: 1) According to the Care section of the BBIA Cardiosave Operating Instructions, "Never place fluids on the top of this unit. Make sure that the vessel and the saline tubing are not hung directly on the BBIA. In the event of an accidental spill, immediately clean and inspect the unit to make sure there are no risks. "2) In an unusual event in which a sudden interruption of therapy occurs, transfer the patient to an alternative BBIA. The Instructions for Use of the Intra-Aortic Balloon Catheter (BIA), reiterates that the catheter should not remain inactive for more than 30 minutes due to the potential formation of thrombi. If an alternative BBIA is unavailable, inflate the BIA manually with air or helium and aspirate immediately, repeat every 5 minutes until BBIA is available, or alternatively the intra-aortic balloon catheter should be removed from the patient. Check the instructions for use of the intra-aortic balloon catheter, and inflate and manually disinfect the catheter. The patient should be treated according to the treatment protocols of his unit and the clinical criteria of the caregivers to ensure hemodynamic stability. 3) If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: // portal .anvisa.gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 04/05/2018 - Date of notification notice to Anvisa: 05/15/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: (...) Art. 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...)
Causa
Possibility of fluids entering the bbia, which can affect several electronic circuit boards. if this occurs, this may prevent the initiation or continuation of therapy.
Acción
Field Action Code 2249723-04 / 26 / 2018-001-C under the responsibility of Maquet Cardiopulmonary do Brasil Industria e Comercio Ltda. Field Correction.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The following steps should be taken: 1) Check your entire stock for the product / lot code combinations affected by this recall. 2) If you have distributed any batch number / code, please contact your customer immediately and alert him / her to the recall by requesting that you return the affected product to Bard Brasil Indústria e Comércio de Produtos para Saúde Ltda. 3) Segregate any identified product from your stock. 4) Once the product affected by this collection is identified and withdrawn from its stock; fill out the form attached to the Letter to the Client. Report exactly the quantities and lot numbers of each product of this recall that you have in stock. 5) If you have used any listed product, complete the recall verification form stating that no product will return. If you have any questions, please contact the company: e-mail Sao-tecnovigilancia@crbard.com. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 04/23/2018 - Date of notification notice to Anvisa: 05/21/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: (...) Art. 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...)
Causa
Product code / lot number combinations include 12 cc luer lock syringes instead of the 12 cc luer slip syringes that were included in the ports kits registry.
Acción
Field Action Code VT-RAP-18-01-003 under the responsibility of the company Bard do Brasil Industria e Comercio de Produtos para Saude Ltda. Gathering.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The following steps should be taken: 1. Check immediately if you still have the catalog and batch (s) in your inventory. If you have units in stock, discontinue and segregate them. 2. Share this notification with any other users of this product at your institution to make sure everyone is aware. 3. Complete the form attached to the letter to the customers, stating whether or not you have any affected product, and send the e-mail BRCR@bd.com, so that the company becomes aware of the receipt of this notification. Proceed with the collection and replacement of the products, if you still have units of the lots informed. 4. Notify the company and ANVISA of any adverse events that occurred, related to the situation described in this notification. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 04/23/2018 - Date of notification notice to Anvisa: 05/16/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: (...) Art. 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...)
Causa
In an investigation conducted by the us fda in relation to patients infected by the bacterium serratia marcescens in the united states of america, it was identified that the patients involved underwent treatments that included, in addition to other products, the use of bd posiflush syringe with heparin . this is a suspicion not yet confirmed. the company is carrying out the collection of the products and anvisa is monitoring the action.
Acción
Field Action Code 24_Abr18 under the responsibility of the company Becton Dickinson Indústrias Cirúrgicas Ltda. Gathering.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Users / patients and distributors should take the following actions: 1. Operators may continue to use the Prismaflex control units that have not displayed the "Out of Range Voltage" malfunction alarm. 2. According to the company, a technical representative will go to your institution to determine the corrective plan and schedule the firmware update. 3. If you purchased this product directly from Baxter, complete the attached customer response form and return it to Baxter via e-mail to faleconosco@baxter.com or fax to (XX) 11 5635-0106 or 0800 012 5522 , even if there is no remaining stock at your facility. Prompt return of the customer response form will confirm receipt of this notification and will prevent you from receiving this notice several times. 4. If you distribute this product to other institutions or departments within your institution, please send a copy of this document to them. 5. If you are a reseller, wholesaler, distributor or original equipment manufacturer (OEM) distributing any affected product to other institutions, please notify your customers about this Urgent Medical Device Correction in accordance with the usual procedures. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 03/03/2018 - Date of notification notice to Anvisa: 05/23/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: (...) Art. 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...)
Causa
Possibility of failure of the device with the electronic components of the pump module. failure mode may result in an "out of range voltage" malfunction alarm, which causes the device to enter a "safe state" and does not function until service is performed. baxter is working on a firmware to correct the problem.
Acción
Field Action Code FA-2018-014 under the responsibility of the company Baxter Hospitalar. Field Correction.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Immediately discontinue use of the affected products (see affected affected fields and serial numbers affected by this alert and details in Attachment A of the Letter to Customer) Quarantine and return unused product codes and batches of listed items. used codes and batches of affected items must be returned as described in the Required Actions section of the Customer Letter.All unused product codes and batches of affected items must be returned to the company or distributors.If you wish to notify technical complaints and adverse events please use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http://portal.anvisa.gov.br/notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution option o / Entity, if you are a professional of an institution / entity. System of Technovigilance: Patient or citizen can notify through the System of Tecnovigilância / SISTEC access through the link http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp - Date of identification of the problem by the company: 05/23/2018 - Notification date for Anvisa: 05/24/2018 The company holding the record of the affected product is responsible for contacting its clients in a timely manner to ensure the effectiveness of the ongoing Field Action. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: (...) Art. 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...)
Causa
Due to the possibility of the device being improperly mounted at the factory, its use may result in failure to form a line of staples when the tissue is divided, leading to bleeding or leakage of luminal contents.
Acción
Field Action Code FAEndo Gia Tri-Staplesob company responsibility Auto Suture do Brasil Ltda. Gathering.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Recommendations (what to do, contacts with the manufacturer, how to notify Anvisa, etc.): Immediately return the affected products to the representative of the company holding the registration. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 05/02/2018 - Date of notification notice to Anvisa: 05/14/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
An arterial cannula used for open heart surgery is usually equipped with a ventilation plug that facilitates cannula deaeration. the registration holder's airway cannula ventilation plug consists of sintered polyethylene, so the structure of the ventilation plug is porous and permeable by gas. after the deaeration process is completed, the client needs to separate the ventilation plug from the cannula to connect the extracorporeal circuit. the company states that in some cases, it was reported that the ventilation plug broke during separation of the arterial cannula (cases occurred outside brazil).
Acción
Field Action Code FSCA-2018-03-27 under the responsibility of Maquet Cardiopulmonary do Brasil Industria e Comercio Ltda. Gathering. Undoing.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Security note from the company OCULUS Optikgeräte GmbH concerning the obligatory update of some versions of Pentacam® AXL software
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
3M Sanayi ve Ticaret AS safety note regarding 3M Steri Drape surgical surgeries and 3M Steri- Drape surgical drums
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Abbott's safety note regarding the battery management tool for Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra implantable cardioverter defibrillators
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Abbott Vascular safety note for bioresorbable vascular scaffold systems Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS Syste
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Abbott safety notice regarding the Clinical Chemistry reagent Urea Nitrogen with lot numbers 97642UN11 and 97668UN11.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Abbott Point of Care safety note for cTnI cartridges for the i-STAT blood analyzer
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Abbott Ireland Diagnostics Division safety notice on falsely elevated ARCHITECT Estradiol test results (cat. No 7K72) in specimens from patients receiving fulvestrant (Faslodex)
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Abbott safety note regarding the use of CentriMag emergency power supply cable for emergency use, Model: 201-10002, (compatible with CentriMag pump and PediVas pump)
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Abbott's safety note regarding the implantable pulse generator (IPG) NM of St. Jude Medical
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Abbott's safety note regarding the implantable pulse generator (IPG) NM of St. Jude Medical