Events

Rappel de Bard Max-Core Disposable Core Biopsy Instrument

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Bard Australia 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-2015-RN-00330-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-04-13
  • 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-2015-RN-00330-1
  • 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
    Bard peripheral vascular (bpv) has identified potential self-activation issues with the instrument during use that may pose an incremental increase in the risk associated with biopsy procedures. this includes prolonging the procedure, requiring the use of an additional device, or minor tissue injury to the patient if the device fails to fire. potential self-activation, may potentially lead to inadvertent injury to deep tissue or structures, blood vessels or adjacent critical organs. in addition, a used device may pose an incremental risk of blood borne contamination to the user if self-activated. in the event this occurred, the patient or user may require urgent medical or surgical intervention and the user is to follow facility procedures for inadvertent needle sticks or injury.
  • Action
    Bard Australia is requesting the customers to quarantine and stop using the affected product. Bard Australia is arranging for any affected product to be returned and replaced. This action has been closed-out on 1/06/2016.

Device

Bard Max-Core Disposable Core Biopsy Instrument
  • Modèle / numéro de série
    Bard Max-Core Disposable Core Biopsy Instrument Product Code: MC 1820Lot Numbers: REYA2017 & REYC2853ARTG number: 180984
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd