Events

Rappel de Edwards Lifesciences QuickDraw Venous Cannula

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-2013-RN-00524-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-05-29
  • 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-2013-RN-00524-1
  • 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
    Through routine post market surveillance data review, edwards lifesciences has identified new risks associated with specific removal techniques for the quickdraw venous cannula product:1. scar tissue at the incision site may create resistance and increase the withdrawal forces on the cannula.2. when using the percutaneous technique; separation of the cannula may occur during removal if too much compressive force is applied at the incision site. this is in addition to the resistance felt if scar tissue is present.
  • Action
    Edwards Lifesciences is asking customers to quarantine any affected product and return these. Cautions for these new risks are being added to the IFU for future shipments of the cannula to provide information to users about this potential risk.

Device

Edwards Lifesciences QuickDraw Venous Cannula

Manufacturer

Edwards Lifesciences Pty Ltd