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
According to the company, "a false reactive PCR result would lead to a misdiagnosis that the patient has anti-PCR antibodies, but as described in the instructions for use, the kit is a test aid in the diagnosis of nonspecific inflammation with rapid onset (1 - 2 weeks) Positive results should always be confirmed by other diagnostic and clinical methods of the patient Another situation presented is agglutination of the reagent even before mixing with the patient sample, making it impossible to determine a Therefore, there are no health risks, since positive results must be complemented and the reagent will often present agglutination even before mixing with the sample, making it impossible for the laboratory to perform the test procedure.
Causa
According to the company, "an increase in the rate of reactive pcr results has been identified (false positive), often the product is agglutinating (positive) even without the presence of the patient sample.".
Acción
Company is making collection of affected lots for destruction. # AFFECTED LOTS: 14C017; 14C109; 14C111 # Attached: 1.Carta to Customers; 2. Distribution Map
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
There is a risk of serious injury to the patient and Technician / Operator as a result of table movement. For the patient: • There is a possibility of withdrawal or movement of invasive medical devices, such as IV, tracheostomy and tracheostomy drapes. To the Technician / Operator: • There is a possibility of crushing point in the subframe; and • A possibility of locking between the table and the Gantry if the Technician / Operator remains between them to move the patient ahead
Causa
If the coupling is not properly locked during operation of the device, the table frame moves freely, causing accidental horizontal displacement. it results in serious damage with probability of occurrence not expected. risk analysis: acceptable.
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 Laboratories safety note regarding HbA1c calibrators, lot No. 45063UQ12
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
According to the company, "a false reactive PCR result would lead to a misdiagnosis that the patient has anti-PCR antibodies, but as described in the instructions for use, the kit is a test aid in the diagnosis of nonspecific inflammation with rapid onset (1 - 2 weeks) Positive results should always be confirmed by other diagnostic and clinical methods of the patient Another situation presented is agglutination of the reagent even before mixing with the patient sample, making it impossible to determine a Therefore, there are no health risks, since positive results must be complemented and the reagent will often present agglutination even before mixing with the sample, making it impossible for the laboratory to perform the test procedure.
Causa
According to the company, "an increase in the rate of reactive pcr results has been identified (false positive), often the product is agglutinating (positive) even without the presence of the patient sample.".
Acción
Company is making collection of affected lots for destruction. # AFFECTED LOTS: 14C110; 14D085 # Attached: 1.Carta to Customers; 2. Distribution Map
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 Health Services that have the affected equipment must ensure that the measures proposed by the Field Action are executed in their equipment. The company reported that its customers were notified on 06/24/2014. Map of Distribution / List of clients in annex.
Causa
According to the manufacturer (covidien), it "is issuing this voluntary field security corrective action (fsca) for certain puritan bennett ™ 840 fans that contain a certain back light inverter (pcba) printed circuit board. of the affected backlight (pcba) is only present on the puritan bennett 840 ventilators with a 9.4-inch graphical user interface (gui) set.This voluntary field safety corrective action is being taken in response to customer reports on the loss of information on the graphical user interface (gui) display while the ventilator continues to provide respiratory support.Customer reports describe that gui display screens (upper and lower) erase during patient use.This event interferes on the doctor's ability to see and / or change the fan settings or the alarm parameters set by him. during these events. ".
Acción
Company will make Correction in the field - Software update - Circuit replacement - Preventive maintenance # Company informed that its clients have been sent the following guidelines regarding the Field Action: 1. Letter of Communication to Clients (Attached); 2. Verification Form (Attached); Questions and Answers (Attached).
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 product may exhibit reduced effectiveness due to failure to form the hydrogel, or even a hydrogel with mechanical resistance. If the product fails to form hydrogel or the hydrogel formed has an inappropriate (mechanical resistance) during a surgical procedure, the surgeon should use a new product kit or adopt an alternative surgical method. Additional information at http://portal.anvisa.gov.br/wps/wcm/connect/29102a80451087f1936fb7c2afb947e8/Message+of+Alerta_VENDA.pdf?MOD=AJPERES #### UPDATED ON 08/18/2017, the documentations of the action field sent by the company are filed in the area. If necessary, the area can reassess the action at any time.
Causa
The effectiveness of the product may be compromised, given that tests carried out by the company have detected results below the specifications regarding the validity of the product.
Acción
BAXTER HOSPITALAR LTDA is collecting the product (affected batches described above). Do not use the product at risk and identify the hazardous units in your stock, segregate them and contact BAXTER or distributor for return purposes. For details on how to proceed, check additional information in the Alert Message posted by the company: http://portal.anvisa.gov.br/wps/wcm/connect/29102a80451087f1936fb7c2afb947e8/Messagem+de+Alerta_VENDA.pdf?MOD=AJPERES
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 action recommended by the manufacturer is palliative and the company informed that a software fix is being developed, but has not determined the deadline for its completion. See details of the field action in the Varian alert message, available at http://portal.anvisa.gov.br/wps/wcm/connect/09468c004510a13a938db7c2afb947e8/Messagem+de+Alerta.pdf?MOD=AJPERES #### Update (10/16/2014): The company reported that the field correction is planned for October 2015. #### Updated 10/25/2017, the company submitted a monitoring report informing the recommendation in the notice of security check of the dosimetry symmetry of the equipment with an extra security system called Yield Interlock, registration 10405410032.
Causa
Unexpected downward trend in beam output on linear accelerators c-series [he] for 6mv, when the photon treatment mode is activated.
Acción
Users should implement a daily verification of the constancy of the output rate of the photon beams, as recommended. It is important that these daily checks include all 6MV [6SRS, 6FFF and 6X] beams. Users should be aware of any sudden decrease in dose output greater than or equal to 3% per day or greater or equal to 6% per week. See detailed information at http://portal.anvisa.gov.br/wps/wcm/connect/09468c004510a13a938db7c2afb947e8/Messagem+de+Alerta.pdf?MOD=AJPERES
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 Coloplast do Brasil Ltda will collect the product. For more information, please contact the company by phone (21) 3212-4259 and email brpr@coloplast.com
Causa
The company importing the product informed that there was an error in the import process and the manufacturer sent the biatain alginato product to brazil in place of the seasorb soft product. the nota fiscal indicates that the product is seasorb soft, but in reality the physical product is biatain alginate. the biatain alginate product is not registered in brazil.
Acción
The company informs that the product should not be used. It directs that the inventory is checked and, if the product is available, that it be segregated. Please check the attachment - Coloplast Customer Letter
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
As a consequence of the problem, the plan exported by the DICOM and the application of subsequent treatments would not correspond to the approved treatment plan. Thus, areas of the patient who should not receive doses may be treated and areas that should be treated may receive a dose that is higher or lower than the correct dose. According to the company's risk assessment, there is a remote possibility that the problem will lead to serious adverse health consequences.
Causa
Incorrect handling when performing a dicom export of arcs using multiple field sequencing.
Acción
The company is providing a software fix for the problem. To avoid adverse events, do not use 180 ° as the starting angle of the gantry of the second bow - using 180.1 ° or 179.9 ° as the initial gantry angle completely eliminates the problem. Users should follow the guidance given in the Important Field Safety Notice and confirm receipt of the notice for the local Elekta contact as soon as possible. The important Notice of Field Security disclosed by the company is available at: http://portal.anvisa.gov.br/wps/connect/d8e83d004513a40c9130d7004acc0eea/Messagem+de+Alerta+%282%29.pdf?MOD=AJPERES
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
As assessed by the manufacturer, this is a situation in which the use of or exposure to the affected product may lead to temporary or clinically reversible adverse health effects, or where the likelihood of serious adverse health consequences is remote.
Causa
The company holding the registration informs that the product vitros® ca 19-9 reagent packs are used in vitros® eci / eciq immunodynamic systems, vitros® 3600 immunodiagnostic systems and vitros® 5600 integrated systems for the quantitative measurement of the defined antigen 1116-ns -19-9 in human serum and plasma. internal tests confirmed positive bias results generated with vitros® ca19-9, lot 1320. results from patient samples and proficiency samples showed positive bias in lot 1320 compared to previous batches.
Acción
The company directs customers to: i- Discontinue use immediately and discard all remaining inventory of CA19-9 Calibrators and Reagent Packs, Lot 1320, ii- Review previously reported results with VITROS® CA 19-9 Reagent Packs, Lot 1320, iii - Discuss with the Medical Director of the Laboratory or the requesting physician any questions you may have regarding previously reported results to determine the appropriate course of action. More information in the Letter to the Client - Annex II
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
According to the company the detected nonconformity makes it difficult to apply the product to the skin during its use. There is no impact on the safety or efficacy of the product, the other characteristics are within the specified.///// UPDATE - 04/09/2014 - The company finalized the field action.
Causa
The company informs that the product is out of appearance (consistency).
Acción
The company is performing collection of the units belonging to this lot. According to the report, the company has already informed its distributors about this field action./////QUALIFICATION - 04/09/2014 - The company finalized the field action.
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 informs that according to international regulations, this event falls into a situation in which the use of, or exposure to, the affected product is unlikely to result in adverse health effects. The inability to generate successful calibration with VITROS® TSH Calibrators and Reagent Packs, Lot 4540 only affects the VITROS® 5600 and VITROS® 3600 Systems. If the laboratory has successfully calibrated the VITROS® TSH Calibrators and Reagent Packs products, Lot 4540 , the VITROS® 5600 and / or VITROS® 3600 System and the quality control results are acceptable, there will be no impact on patient outcomes.
Causa
Ortho clinical diagnostics (ocd) has received complaints from customers who failed to generate a successful calibration using vitros® tsh calibrators and reagent packs, lot 4540, on the vitros® 5600 and 3600 systems. the company reports that it has not received calibration failures on the vitros® eci / eciq systems.
Acción
The company informs that: i - If the laboratory has a VITROS® ECi / ECiQ System, it is possible to continue using VITROS® TSH Calibrators and Reagent Packs, Lot 4540, in the VITROS® ECi / ECiQ System. The OCD recommends that you allocate the remaining inventory of Lot 4540 for use only in the VITROS® ECi / ECiQ System; ii - If the laboratory has only VITROS® 5600 and / or VITROS® 3600, OCD will credit the account or replace the remaining customer inventory of VITROS® TSH Calibrators and Reagent Packs, Lot 4540 if you are unable to use this lot in a VITROS® ECi / ECiQ System; iii- If you have successfully calibrated VITROS® TSH Calibrators and Reagent Packs, Lot 4540, you can continue to use the current inventory until you receive the replacement product as long as the quality control results for TSH are acceptable; iv - To avoid this failure again in the future, discontinue use and dispose of all VITROS® TSH Calibrators and Reagent Packs, Lot 4540, after receiving the replacement product. For more information, please check the Letter to the Client - Annex II
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 Laboratories announcement on Masters AxSYM Rubella IgG reagents and calibrators and Rubella IgG calibrators and controls (19.06.2008)
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
Fill out and send the Kis Recall Notification form for withdrawal and replacement of the product. Access Security Card at: http://portal.anvisa.gov.br/wps/wcm/connect/b2e1558045699635840fc4e23d5c835b/Carta+Seguran%C3%A7a_Biomerieux.pdf?MOD=AJPERES
Causa
A nonconformity was detected on the vitek 2 gn - identification card for gram negative, when some escherichia coli isolates were tested. it was determined that for the aglu substrate, some false positives may occur for some strains of escherichia coll, causing an incorrect identification of e. coli isolates, such as serratia fonticola.
Acción
Ensure that the guidance letter has been dis- tributed and reviewed for all appropriate personnel within the organization. Analyze your current inventory of caths 2 Negative Gram Identification. If you still have Kits of the affected product (Ref. 21341, Lot 241289140), discontinue use of the same and contact the Customer Service of Biomerieux for collection and replacement of the product.
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 semi-annual maintenance tests indicated that the analyzed sample did not meet the certification criterion, being rejected in the dimension test of size 8.5 and impermeability.//// UPDATE 01/15/2016 - The IFBQ reported that it revoked the suspension of the Authorization for the Use of the Conformity Identity Seal after verifying that the company has implemented the proposed corrective actions as well as obtained approval during the tests required by the product regulation.
Causa
Suspension of the authorization for the use of the identification seal by the product certification body (ocp) due to the failure in the dimensional test of size 8.5 and impermeability.
Acción
The company is carrying out Field Action for the collection of products manufactured from the date of the last certification - 04/07/2013.
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 should trigger product recall action.
Causa
According to the single sample tax review report 851.00 / 2014, issued by the adolfo lutz institute, ultra gel ultra product, val. 05/2015, lot 299/13, was considered unsatisfactory in the aspect test with presence of particles in and adhered to the inner wall of the bottle.
Acción
Resolution RE No. 3,380 of September 2, 2014 determined, as a measure of health interest, the suspension of distribution, trade and use, as well as the collection, throughout the national territory, of the product Ultra Gel Ultra, Val. 05/2015 , lot 299/13.
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
According to the company Politec Importação e Comércio Ltda., "It is advisable to closely monitor patients who are known to have been treated using these affected location wires and are still at risk of developing infectious complications. responsible doctor. "
Causa
The bard dualok seal injury wire may inadvertently penetrate / puncture / cut off its original packaging, thus breaking its sterility barrier and bringing the product into contact with the outside of the packaging. the problem described may increase the risk of injury, including complications associated with localized or systemic infections, which may require medical intervention to prevent serious injury.
Acción
Company will make the collection and return it to the manufacturer, located in the United States. Code 170/2014.
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 factory audit performed within the maintenance process of the Seal of Identification of Conformity demonstrated that the company changed the sterilization process for the product, being in disagreement with the information sent to ANVISA.////////// UPDATE: The company completed the field action, according to report sent on the date of 01/29/2015.
Causa
Suspension of authorization for the use of the conformity identification seal by the product certification body (ocp) motivated by the factory audit where it was noted that the surgical gloves were sterilized by a different method from the product registration.
Acción
Company shall initiate Field Action for the collection of products manufactured from the date of the last factory audit, held on April 23 and 24, 2014.
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
According to the company's statement, all equipment was 100% evaluated before its release to the market, presenting results in accordance with the specifications defined therein, including calibration, ensuring that they are suitable for use. The company claims that the equipment complies with the specifications and there is no consequence in the use of the products.
Causa
B. braun laboratories has identified that the certificates of the above serial numbers of the enteromat compact infusion pump equipment have been issued with incorrect information in the fields intended for calibration results. this is a human error, unique and exclusively related to the stage of issuing the certificates.
Acción
The company that holds the registration in Brazil requests the return of the incorrect Calibration Certificates that are in the possession of the customers, which will be replaced by the duly corrected revision.
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 should trigger the collection of existing stocks in the market. Customers who have purchased the product should contact the manufacturer in order for the manufacturer to collect all units sold in disagreement with health legislation.
Causa
Manufacture and commercialization of product without registration in anvisa by the company jsm industria e comercio de productos manufaturados ltda - 04.782.901 / 0001-33. (distribution map attached).
Acción
Anvisa determined the suspension of the manufacture, distribution, disclosure, commercialization and use of the product COLLECTOR OF DRILLING-BUCKET, as well as the collection of existing stocks in the market
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
According to the manifestation of the company, corrective and preventive measures have already been adopted to solve the problem generated. The company is already performing the action of collection of the lot. //// UPDATE - 08/29/2014 - The company has already finalized the field action (started in April / 2014, due to the publication in the Official Gazette of the City of São Paulo of the COVISA Communiqué 015/2014). The products collected were sent to TWM Soluções Ambientais Ltda Waste Management on 08/22/2014.
Causa
According to the single sample fiscal analysis report no. 1082.00 / 2014 issued by the adolfo lutz institute, the neve sterile gauze compressa neve sterile product, lot 5954, was considered unsatisfactory in the appearance test, in which the presence of a dark foreign body inside the intact package was found.
Acción
Resolution RE No. 3,168 of August 19, 2014, determined, as a measure of health interest, the suspension of distribution, trade and use, as well as the collection, throughout the national territory, of the product Gaze Surgical Gauze Neve Estéril, Val. 9/2018, lot 5954.
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
1. Upon reaching the intended proximal access zone, visually confirm that the distal marking bands of the stent can be seen approximately 2 cm out of the outer primary sheath. 2. If the distal marking bands of the stent do not appear to have come out of the External Primary Sheath, while in Position 1, grasp the Stationary Gray Stamping Tweezers while pulling back the Black Stationary Tweezer until the marking bands distal from the stent exit of the External Primary Sheath by approximately 2 cm.
Causa
A difficulty was observed in the handling of the prosthesis transport system as set forth below: it was observed that in a small number of cases, the internal secondary sheath may not have completely exited the external primary sheath upon reaching the black line. in this situation, the distal end of the stent will also remain inside the external primary sheath. failure to recognize this condition prior to deployment could lead to deployment difficulties or deployment failures. there is no impact on devices already deployed.
Acción
Updating, correcting or supplementing the instructions for use.
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
According to the company, "affected lots do not have the potential of associated risks, because they are currently valid, without any risk to the patient, so there are no consequences of using these lots."
Causa
The product of offroad reintroduction catheter is composed of two components, contained in an external cardboard box: the balloon catheter of posiconamento and the lancet of the microcatheter. the company has identified that the outer carton contains a validity period of two months beyond the actual expiration date. however, the actual expiration date of each of the components is presented correctly in their individual inner packages.
Acción
The company decided to collect the affected products - Pickup for return to the manufacturer. - Offroad Code 01-2014. (LETTER OF NOTIFICATION TO THE CLIENT IN ANNEX).
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
Determine, as a measure of sanitary interest, throughout the national territory, the suspension of the distribution, trade and use of lot 1883G (val .: 06/2018) of the product SINGLE HYPODERMIC SINGLE SYRINGE FOR MANUAL USE - NEEDLE, manufactured by Company Saldanha Rodrigues Ltda.
Causa
One-sample tax report, issued by the oswaldo cruz foundation's national health quality control institute, considered unsatisfactory in the analysis of appearance, in which a hole was found in a primary package, impacting the sterility of the product, and was observed, still, the presence of whitish spots in the inner part of the cylinder of nine units.
Acción
Determine to the manufacturer company the collection of existing stock in the market, related to lot 1883G (val .: 06/2018)
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 to users: "To avoid the potential risk of this problem, Siemens recommends: - Perform the leak test for the transesophageal transducer before each use (this test may indicate cracks, cuts, tears, perforations and protuberances in the joint material , and thus avoid possible risk to the patient and / or operator) - Use only Siemens approved cleaning and disinfection solutions - Carefully follow manufacturer's instructions - Use commercially available transducer guides designed specifically for TEE applications. Follow the instructions provided by the manufacturer of the transducer guide - When storing the transesophageal transducer, take extreme care to keep the transducer tip vertically - Never move the transducer end by hand Always use the flexible controls Recommended steps are provided in the existing user's manual of the ultrasound system. s have been instructed to share the information contained in the letter with all employees in your organization who need to know about this problem and to file the letter with the Operator's Manual. "
Causa
Siemens has identified the possibility of deterioration of the material covering the articulation section of the transesophageal transducer v5ms.
Acción
The base installed in the system will be corrected. Code: US024 / 14 / S (LETTER TO THE CLIENT IN ANNEX)