Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: baxter healthcare vented paclitaxel set
medical device manufacturer, baxter healthcare has issued a medical device safety alert concerning vented paclitaxel set. the affected product code and lot numbers are as follows:
product code (lot number): mmc9627s (14h13v434)
product code (lot number): vmc9627 (14i05t696, 14k19t380, 15b17t404)
the manufacturer is voluntarily issuing a recall for the above referenced lots due to complaints for leaks at the spike’s air vent subassembly.
according to the manufacturer, a leak in a paclitaxel set may result in a breach in sterility of the fluid path with subsequent contamination of the solution. if the leak was not detected during priming or initial set up, it would lead to serious adverse health consequences.
besides, the leak may result in skin contact that would lead to potential irritation of skin.
the manufacturer is advising users to inspect and quarantine any affected stock for return to the manufacturer.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 5 november 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bayer glucofacts deluxe software version 3.01
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning glucofacts deluxe software version 3.01 manufactured by bayer healthcare.
according to bayer, with english as the language setting within glucofacts deluxe software, the default time format used for display is a 12 hour time format (am/pm). the issues with glucofacts deluxe software version 3.01 include the following:
"am" and "pm" designations do not appear in association with the time stamp in the logbook view,
pm times are listed with a "0" in front of them for times earlier than 10:00 pm. for example, 5:00 pm is reported as 05:00.
bayer explained that the results viewed on the meter are not affected by the time stamp issue. this issue only occurs when results are viewed on a computer.
to interpret the results and the associated time stamps appropriately in the logbook view of glucofacts deluxe, bayer advised the users to review the column headings for the appropriate time of day. in addition, bayer will provide a software update which will be available online to correct the issue.
for details, please refer to the following mhra website:
http://www.Mhra.Gov.Uk/safetyinformation/
safetywarningsalertsandrecalls/fieldsafetynotices/con184398
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 11 september 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bd alaris pump module model 8100
the health sciences authority (hsa) of singapore has posted a medical device safety alert concerningalaris pump module model 8100, manufactured by bd. the affected devices are identified as follows:-
alaris pump module model 8100 (large volume pump) manufactured or serviced by the bd service depot from june 2002 to june 2004.
alaris pump module door latch kit (p/n 147503-000) shipped from june 2002 to june 2004
the manufacturer has identified a specific scenario that could cause unintended flow in the older, centered sear door latch design in the alaris pump module model 8100. this scenario is reproducible under the following situations:
a) the user does not close the roller clamp on the iv administration set before the pump door is opened as recommended, and
b) opening the pump door using an atypical technique with the door latch with the centered sear design.
the user can reproduce a free-flow condition if the clinician does not close the roller clamp on the iv administration set prior to opening the pump door and the pump door is opened by using a flick of the door latch that causes the door to pop open instead of opening the door by slowly raising the latch. this flicking motion may cause the centered sear design to not effectively engage with the safety clamp fitment.
both of these actions leave the roller clamp and safety clamp fitment in the open position which can cause unintended flow possibly resulting in an over infusion to the patient. the affected product is the centered sear door latch manufactured between june 2002 to june 2004.
according to the manufacturer, safety clamp fitment inactivation due to non-optimal engagement of sear to the slide clamp could result in an over infusion. over infusion can result in serious life-threatening patient injury.
to prevent this from occurring, users are advised to close the roller clamp prior to opening the pump door, all dedicated intravenous administration sets have a warning tag affixed to the tubing and the front cover of the pump module has a warning stating "close clamp before opening door" to assure that the roller clamp is properly closed. this is also instructed in the alaris system user manual.
users are also advised to visually examine the affected device to determine if the door latch has a centered-sear flange (the door latch mechanism may have been replaced after manufacture with an off-centered sear design). the centered-sear safety clamp fitment is identified by the centered position of the metal pivot post located on the inside of the door latch assembly sear flange:-
if the device has a centered-sear safety clamp fitment, clearly mark and sequester (e.G. biomed department) the alaris pump module. notify the manufacturer to coordinate an onsite remediation or send the devices to the manufacturer’s service depot.
if the device has an off-centered safety clamp fitment, the device does not require remediation.
for details, please refer to the hsa website: http://www.Hsa.Gov.Sg/content/hsa/en/health_products_regulation/medical_devices/product_owners_fsn/2017/june.Html
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 26 july 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bayer healthcare 25-foot dc power cables shipped with medrad veris mr vital signs monitors
medical device manufacturer, bayer healthcare, has issued a field safety notice concerning 25-foot dc power cables shipped with medrad veris mr vital signs monitors between february 2009 and february 2013 (catalogue number 3010556).
according to the manufacturer, the affected power cables are being recalled due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket. when the dc power supply is connected to both ac power (wall outlet) and the dc power cable, excessive heating of the dc power cable may occur.
the manufacturer advises users to have visual inspection of the dc power cable against recall criteria provided by the manufacturer. the affected dc power cables confirmed by visual inspection will be replaced with new dc power cables. in the interim, users can still use the dc power cables by following instructions for safe use of dc power cable provided by manufacturer.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 26 april 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bayer medical care medrad spectris solaris ep mr injection system
medical device manufacturer, bayer medical care, has issued a medical device safety alert concerning its medrad spectris solaris ep mr injection system [catalogue number: 3012011; serial number: 202052].
the manufacturer has determined that the battery/cable power assemblies in spectris solaris ep mr injection systems (ssep) distributed from september – november 2016 do not meet the specifications. this could result in intermittent power failure of the device which could result in a degraded image or a delay of the imaging procedure requiring a repeat of the contrast-enhanced mr scan should it occur during a procedure. the manufacturer will replace the battery/cable power assembly for the affected users.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 26 january 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: medrad® continuum pump and tubing set
medical device manufacturer, medrad, inc. has initiated a field safety corrective actions concerning medrad® continuum pump and tubing set [catalogue numbers: mik 200a, mil 200b, 3009135, 3015550, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159 and 3015161].
the recall is initiated because the tubing exhibits a variation that, when used in conjunction with any continuum pump, may result in flow rate accuracy performance issues.
in addition, the manufacturer is also recalling the continuum pumps, calibrated using the tubing associated with this recall.
for those serial numbers not affected by this recall, users are advised to follow the instructions enclosed to reset the maximum flow rate of their continuum pump(s) for future operation with the new tubing.
according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medrad continuum mr infusion system - pump
health canada has issued a medical device safety alert concerning continuum mr infusion system - pump, manufactured by medrad inc. the affected lot numbers are 3008236, 3009135, 3009917 and 3009966.
the manufacturer has identified that there have been incidents resulting in magnetic attraction caused by a damaged locking pin. the locking pin is found in the pump retaining bracket and is used to securely hold the pump in the bracket in the mr environment.
the manufacturer has advised users to cease use of affected products immediately and remove the product from the mr scan room.
for details, please visit the following health canada website:http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/38611r-eng.Php
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 26 march 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bd alaris system pc unit model 8015
the health sciences authority (hsa) of singapore has posted a medical device safety alert regarding alaris system pc unit model 8015, manufactured by bd.
according to the safety alert issued by the manufacturer, system error 255-16-275 can occur when a user selects two functions at the same time/rapid succession or not following typical workflows. this results in a synchronization issue between the pc unit and the modules. below are five examples:
closing the pump module door and in rapid succession (less than 1 second apart) pressing start.
priming and starting system in pause state and then attempting to remove the new syringe.
starting an infusion using the delay options. then confirming the delay entry and pressing channel select on another module at the same time.
locking pca door before confirming on screen popup that occurs on another module.
pressing channel off on two syringe modules after completion of infusions at the same time.
the system error would result in a non-silence-able, high priority alarm and status indicator lights on modules will flash red. the pc unit displays an error code of 255-16-275. if the system error occurs, all attached modules that are actively infusing will continue to infuse without the ability to titrate infusion parameters. the user may decide to reboot the system or re-program the device to titrate the infusion and/or to silence the alarms. this could result in the clinical decision to interrupt the infusions. an interruption in infusion can result in serious injury.
the affected alaris system will not need to be remediated. affected users are instructed to refer to the user manual addendum to avoid the occurrence of this system error.
for details, please refer to the hsa website:
http://www.Hsa.Gov.Sg/content/hsa/en/health_products_regulation/medical_devices/product_owners_fsn/2017/june.Html
posted on 26 july 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: viterion v100 and v500 telehealth monitors
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning viterion v100 and v500 telehealth monitors manufactured by viterion telehealthcare.
according to viterion, the affected models v100 and v500 do not accept out-of-measuring-range results, i.E. results marked “hi” or “lo” from certain blood glucose meters. the affected meters are bayer’s contour and roche’s accu-chek advantage 03 and 04 meters. this out-of-measuring-range data is not being sent from the patients’ telehealth monitors to the clinician application software (eunet), and hence the healthcare professionals are not able to review the out-of-measuring-range patient blood glucose data.
moreover, for those patients with diabetes who are instructed by their healthcare professional to enter blood sugar results manually on these monitors, only results between 1.1 and 33.3 mmol/l may be entered. results outside of the meter’s measurable range cannot be manually entered on these viterion monitors.
viterion advises the affected patients, who see hi or lo displayed on the blood glucose meter, to contact their healthcare professional immediately. besides, healthcare professionals should watch out for any ‘skipped’ or ‘timeout’ values seen in patient reports.
according to the local supplier, the affected products have not been distributed in hong kong.
for details, please visit the following mhra website:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/
fieldsafetynotices/con213146
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 11 december 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Press release
Causa
Recall of bayer's contour and contour ts glucose test strips the department of health (dh) today (august 16) directs a local medical device supplier, bayer healthcare limited (bayer), to recall from consumers all batches of its two products, namely contour and contour ts glucose test strips, as ongoing in-house quality assurance scheme by the manufacturer has detected the production of erroneously low blood glucose readings.
since the consequential hyperglycaemia in users may pose dreaded and even fatal health risks, the recall is therefore a necessity for safeguarding public health .
bayer reports to dh that the issue came to light when the manufacturer, bayer healthcare diabetes, found on routine testing that strips from half of the bottles of 5s, 10s and 25s produced falsely low blood glucose readings. in-house investigation findings so far point to interaction of the strips with the gas trapped inside the bottles as the cause of the defect.
"given that so far there is no indication that the strip and the packing method for each of the four package sizes is unique and not identical, and the lack of a satisfactory explanation for the sparing of the 50-unit bottles, dh considers it only prudent to advise for a blanket recall of all four package sizes, the 50-unit one included. the recall scope will be reviewed on availability of new evidence," a dh spokesman explains.
"that dh is also advising the recall of contour although bayer only sold contour ts in hong kong is because as the manufacturer has already found out that the former is affected as well and given the high prevalence of diabetes mellitus worldwide, international travellers included, plus the popularity of internet sales, we consider the inclusion of contour test strip as an integral element of a global control effort," the spokesman elaborates.
indeed, bayer's sales record shows that contour ts has been sold to public and private hospitals, private practitioners and also retailers. in connection, dh has informed the hospital authority, all private hospitals and nursing homes. it is understood that bayer has set up phone hotlines at 2814 5121 and 2814 4846 for handling enquiries.
"so far, there is no evidence to suggest that bayer's other glucose test strips, including that for use with the breeze 2 meter on sale locally, are affected. moreover, no related adverse incident report has been received either here or worldwide. however, dh will continue to investigate, including working with overseas counterparts, for both the cause and the scope," the spokesman emphasizes.
"consumers are advised to switch to unaffected options in the market for blood glucose monitoring. however, pending the availability of an alternative in hand, consumers must not discontinue monitoring with any of the affected strips as the risk of not monitoring their blood glucose may outweigh erroneously low blood glucose readings obtained under the present circumstances. in any case, they ought to consult their healthcare providers for switching advice, or whenever in doubt or feel unwell," the spokesman urges.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: baylis medical protrack microcatheter
medical device manufacturer, baylis medical, has issued a medical device safety alert concerning its protrack microcatheter. the affected part and lot numbers are as follows:
part number (lot number): cic35-145 (cifa131113, cifa100614, cif8100714, c1fa241014)
part number (lot number): cic38-145 (cifa161013, cifa271113, cifa311213, cifa210214, cifa070314, cifa270314, cifa070514, cifa210514, cifa240614, cifa100714, cifa180814, cifa080914, cifa221014, cifa050115, cifa210115 and cifa060215).
the manufacturer is voluntarily recalling 20 lots of protrack microcatheter (cic35-145, clc38-145) due to the possibility that the catheter may have circumferential cracks along its length. the cracks may result in leakage of fluids along the catheter.
according to the manufacturer, there have been no adverse event reports related to this discovery.
affected users are advised to immediately segregate all affected product and ensure that it will not be used. product replacement is on-going.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 3 november 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bard hickman and leonard central venous catheter kits
medical device manufacturer, bard access systems, inc., has issued a medical device safety alert concerning its hickman and leonard central venous catheter kits. the affected product code numbers are as follows:
code numbers: 1) 0600560 ; 2) 0600564; 3) 0600580; 4) 0600600; 5) 0600604; 6) 0600620; 7) 0600630; 8) 0600634; 9) 0600650; 10) 0600654; 11) 0606560; 12) 0606564
the manufacturer became aware that an incorrect expiration period was assigned for the introducer needle of three lots included in various central venous catheter products (hickman and leonard catheters). a 15 year expiration period was assigned to the needle lots when the actual expiration period should have been about 5 years.
according to the manufacturer’s health hazard evaluation report, this issue is unlikely to pose an incremental risk of harm.
the manufacturer advises affected users to refer to the field safety notice (fsn) for the proper expiration date of the kit due to the needle.
this notification does not impact any consumed product or patients with these catheters implanted. the product can be used with the understanding of the correct expiration date mentioned in the fsn.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 7 april 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: carefusion alaris gp infusion system
it has come to our attention that medical device manufacturer, carefusion has issued a field safety notice regarding the alaris gp infusion system with the following model numbers: 80063un01, 80263un01, 80263un01-g, 9002med01, 9002med01-g.
the manufacturer through its post market surveillance system learned that the alaris gp infusion system produces very small air bubbles (less than 50 μl) which are too small to trigger the lowest configurable air-in-line detection thresholds (alarm) of the alaris gp infusion system being 50-500 μl as configured by the user or 1ml over a rolling 15 min. window (which is considered state of the art and in compliance with en 60601-2-24: particular requirements for the safety of infusion pumps and controllers)
the air bubbles appear to be generated within the fluid path of the (porous) silicone pumping segment of the administration set during an infusion. the volume and frequency of air bubbles being generated during infusions is influenced by the rate of the infusion, by the height of the pump above the patient and the extent of degassing of drugs. once generated the air bubbles are then transported with the infusion fluid and will generally be delivered to the patient.
a bolus of air into the vascular system may result in pulmonary (venous) air embolism or arterial air embolism. this is believed to put patients with a clinical condition referred to as atrial septal defect at elevated risk.
the manufacturer is not aware of any reports of fatal venous or arterial air embolisms that occurred during the use of affected product having functional air-in-line detectors. this suggests that the affected product provides sufficient protection from an air embolism.
the remote but unacceptable potential for a death or serious injury however suggests that action is justified to prevent further use of affected product without users considering additional safety precautions to elevated risk detailed in the specific clinical condition.
the manufacturer advised users of the alaris gp infusion system to follow the new instructions and warnings in the dfu content and thus the use of a carefusion administration set with an air filter or a standalone filter for the patient group diagnosed with atrial septal defect.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 14 november 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: biomérieux vitek 2 gram-negative ast cards
medical device manufacturer, biomérieux, has issued a medical device safety alert concerning its vitek 2 gram-negative ast cards.
the manufacturer has identified a performance issue with colistin (cs01n). eucast and clsi recently issued a joint recommendation that broth-microdilution (bmd) is the only validated method for antimicrobial susceptibility testing (ast) of colistin. as the vitek 2 ast-gn colistin (cs01n) was developed to agar dilution (ad), an internal biomérieux investigation was conducted to identify any shift in performance for colistin (cs01n) since the vitek 2 colistin (cs01n) test was developed. investigational testing included vitek 2, broth-microdilution and agar dilution using 290 isolates with varying degrees of susceptibility and resistance to colistin. two qc organisms (e.Coli atcc 25922 and p. aeruginosa atcc 27853) were also included in the testing. minimal inhibitory concentration (mic) results from the three methods were compared and evaluated.
according to the manufacturer, the investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the vitek 2 ast-gn colistin (cs01n) compared to agar dilution (the reference method used for cs01n development) and compared to broth-microdilution (recommended method by eucast/clsi). since the development of vitek 2 ast-gn colistin (cs01n), higher resistance rates have been reported. in november 2015 plasmid mediated transferable colistin resistance (mcr-1 gene) was reported and heterogeneous resistance is reported more frequently.
evaluation of the identified issue indicates the potential for false susceptible colistin results. a false susceptible result could have a negative influence on the treatment decision as the drug may be chosen for therapy. inappropriate treatment could be prescribed resulting in treatment failure.
the manufacturer advises users to perform an alternate method of testing prior to reporting colistin (cs01n) results.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 19 may 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bard truguide disposable coaxial biopsy needles
medical device manufacturer, bard peripheral vascular, inc., has issued a medical device safety alert concerning its bard truguide disposable coaxial biopsy needles [part number: c2016b, lot numbers: rewl0924, rexa1695, rexb1529, rexc1632].
the manufacturer has confirmed that the product code/ lot number combination listed above may be at risk of having an incorrectly sized blunt tip stylet within its packaging that will not pass through the coaxial. specifically, the product should contain a 19 gauge blunt tip stylet when the actual packaged product contains a 17 gauge blunt tip stylet.
according to the manufacturer, the potential hazard associated with attempting to proceed in the placement of the coaxial utilising the sharp trocar stylet, instead of the intended optional blunt tip stylet, may be variable depending on the anatomical location of the biopsy and may pose an incremental risk of unintended injury to tissue, vasculature, or other organs. if the affected device has already been safely used, then no further product related action is required.
product recall is on-going.
according to the local supplier, the affected products are not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 15 february 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bard denali inferior vena cava (ivc) filter
medical device manufacturer, bard peripheral vascular, inc. (bpv), has issued a medical device safety alert concerning its denali ivc filter. specific product code/lot number combinations of denali ivc filter are affected and the affected code numbers are as follows:
dl900j: denali filter - jugular/subclavian delivery system
dl900f: denali filter - femoral delivery system
dl950j: denali fitter - jugular/subclavian delivery system
dl950f: denali filter - femoral delivery system
on 18 december 2015, nordson medical, notified bpv of an issue with the stop cock that is included in the denali ivc filter introducer set. according to nordson medical, specific lots of stop cocks are at risk of having cracks in the stop cock body.
according to bpv, all assemblies including the stop cock, are 100% tested to ensure no leaks are present in the assembled device during the manufacturing process. furthermore, bpv recently conducted simulated clinical use testing utilising product with visible cracks on the stop cock. all testing passed the criteria of not leaking. as such, bpv concluded that the cracking is superficial in nature with no impact on product performance or patient safely.
a clinical health hazard was performed by bpv considering all potential clinical issues that could arise from a crack in the indicated location. this assessment concluded that, in the worst case, if an unsuspecting user utilised a denali ivc filter with a cracked stop cock, it is possible that a drop of fluid could form on the stop cock during flushing of the introducer or during the negative pressure associated with aspiration a small amount of air could be drawn into the syringe. in both cases, it is unlikely that the leak would be noticed by the user.
bpv is removing the affected products from the customers impacted by the nordson recall.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 18 february 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bd bbl fildes enrichment
medical device manufacturer, bb diagnostic systems, has initiated a field safety corrective action concerning bd bbl fildes enrichment [catalogue no.: 211866; lot no.: 2079066, 2096375, 2216092, 2227271].
the manufacturer has determined through complaint investigation that the above-referenced lot numbers of product are failing to support the growth of haemophilus species.
the affected users are advised to discontinue use and discard any remaining products. due to an anticipated delay for the available of fildes enrichment, the manufacturer will substitute difco supplement b with reconstituting fluid (catalogue no. 227610-6 x 10ml) as the replacement product.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 17 january 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: bd bbl dryslide pyr kit and bd bbl dryslide oxidase kit
medical device manufacturer, bd, has issued a field safety notice concerning bbl dryslide pyr kit (catalogue number: 231747, lot number: 2276481) and bbl dryslide oxidase kit (catalogue number: 231746, lot number: 2222008).
bd has confirmed through complaint investigation that during the manufacturing process portions of the test slides in the above referenced products were placed into the incorrect product packaging. this could result in intermittent quality control failures and false results. the manufacturer advises to discontinue and discard affected products and product replacement can be arranged.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 26 april 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: carefusion alaris pump module
the united states food and drug administration (fda) has issued a medical device safety alert concerning alaris pump module (model 8100) with software version 9.1.18 manufactured by carefusion inc. the affected devices were manufactured from 6 february, 2014 to 8 april, 2014 and distributed from 7 february, 2014 through 7 april, 2014.
the manufacturer is recalling the alaris pump model 8100, version 9.1.18, because it may have a software failure where the pump module will not properly delay an infusion when the "delay until" option or "multidose" feature is used. the firm received one report where the device malfunctioned when the “delay until” option was selected.
the software failure also causes the pump to not properly deliver a multidose infusion as expected under the following conditions:
when the first dose is programmed to infuse when the system time is earlier than 7 pm (19:00) and a subsequent dose is intended to infuse between 19:00 and 11:59 pm (23:59); and
when the first dose is programmed to infuse when the system time is between 19:00 and 23:59 and a subsequent dose is intended to infuse between 12 am (00:00) and 6:59 pm (18:59) the next day.
affected customers were informed that if the infusion starts earlier or later than intended and is not immediately detected and stopped by the clinician, serious injury or death could result.
the manufacturer advises users not to use the alaris pump module “delay until” option and not to use the “multidose” feature. furthermore, the manufacturer will contact all affected customers to schedule the installation of software version 9.1.17. as an interim guidance, customers may update their dataset to disable both delay options and/or multidose across all profiles to prevent the use of “delay until” option and/or “multidose” feature. these are shared configurations with the alaris syringe module and if disabled would prevent use of these features with the alaris syringe module as well.
for details, please refer to the following fda website:http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm398178.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 21 may 2014.