Events

Rappel de Edwards Lifesciences Vent Catheter

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Edwards Lifesciences Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-01106-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-10-14
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01106-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Edwards lifesciences has identified a potential patient safety risk which may occur during the use of venting catheters. the malleable stylet which aids during insertion of the vent catheter is coated with a white plastic. the white plastic on the stylet has the potential to become damaged through interaction with the hard plastic suction adapter on the vent catheter. this can result in the disruption of the white plastic coating on the stylet. there is an increased chance of generating particulate if the stylet is withdrawn with sharp bends and/or reinserted into the vent catheter. reinsertion may lead to an increased potential for particulate to enter the vasculature.
  • Action
    Edwards is adding the following additional warnings to the instruction for use: - Do not reinsert the stylet after initial removal. If repositioning of the vent catheter is necessary a new device must be used. - Check the stylet for damage during removal from the vent catheter. If the stylet appears damaged, discontinue retraction and remove the vent catheter and stylet together. - The device is designed and intended for use with suction only. Customers are advised that the customer letter needs to be passed on to all those within their organization to understand the changes that Edwards has made to the instruction for use and contraindication. This action has been closed-out on 18/03/2016.

Device

Edwards Lifesciences Vent Catheter

Manufacturer

Edwards Lifesciences Pty Ltd