Events

Rappel de Plastic Cannula – 11 gauge

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par CareFusion Australia 316 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-2017-RN-01163-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-09-06
  • 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-2017-RN-01163-1
  • 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
    Becton dickinson (bd) has identified punctures in the blister packaging detected during the packaging process for specific lots of plastic cannula – 11 gauge.A breach in the sterile barrier has the potential to render the device non-sterile. it is possible end users may not detect the pin holes, thus utilising impacted product clinically. this could result in harm to patients especially when immunocompromised.In association with this recall, bd has decided to discontinue catalogue number: 9391-0200.To date, bd is not aware of any report of injury attributed to this defect in australia.
  • Action
    1. Users are to discontinue use of and segregate the identified Lot Numbers of Catalogue Number 9391-0200 (Plastic cannula – 11 gauge). 2. Complete the supplied Customer Acknowledgement Form to confirm receipt of this notification. 3. Becton Dickinson is requesting that any impacted inventory be returned. 4. Becton Dickinson will arrange for the pick-up of your affected stock and issue a credit to your account.

Device

Plastic Cannula – 11 gauge
  • Modèle / numéro de série
    Plastic Cannula – 11 gauge Catalogue Number: 9391-0200Lot Numbers: 1470303001, 1470304601, 1470306301, 1470311301, 1470314801, 1570314802, 1570317701, 1570317702, 1570317704, 1570322001ARTG Number: 189737
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd