Events

Rappel de Secondary Set Oncology

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-00465-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-10
  • 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-00465-1
  • 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
    The manufacturer, becton dickenson (bd) has received reports of cracking of the secondary set back check valve male luer resulting in leaking of the infusion fluid. during use of the set, a leak occurs at the connection between the needle free valve and back check valve (bcv) connection. leakages can cause delay of infusion, interruption of infusion, exposure to infusates, or under-infusion. bd has not received any reports of serious injury or death associated with the separation or leaks. bd is not aware of any report of injury attributed to this defect in australia.
  • Action
    BD is advising users to discontinue use of and segregate the identified units, and then return to BD. Replacement stock or credit will be provided.

Device

Secondary Set Oncology
  • Modèle / numéro de série
    Secondary Set Oncology Catalogue Number: 72951NE Lot Numbers: 1000089, 1000129, 1000208, 1000468, 1000469, 1000687 and 1000713ARTG Number: 125916
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd