Events

Alerte De Sécurité sur Denali Inferior Vena Cava (IVC) Filter

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Bard Peripheral Vascular.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-02-18
  • Date de publication de l'événement
    2016-02-18
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160218b.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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.

Device

Denali Inferior Vena Cava (IVC) Filter
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Bard Denali Inferior Vena Cava (IVC) Filter
  • Manufacturer
    Bard Peripheral Vascular

Manufacturer

Bard Peripheral Vascular