Events

Rappel de Bard EnCor Needle Guide Insert (part of the EnCor Breast Biopsy Probe)

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-2016-RN-01101-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-23
  • 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-2016-RN-01101-1
  • 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 has identified that the affected lot numbers may be at risk of having an incorrect encor accessory needle guide insert. specifically, a smaller diameter (12g) insert may be contained within the larger (10g) package. this will render the device unusable and the user will need to replace the incorrect needle guide with one of the correct size. to date, bard have received 6 complaints from customers that have received the smaller product in error; none have resulted in an adverse event to patient or loss of functionality of the encor probe.
  • Action
    Bard is advising users that if the incorrect Needle Guide Insert is contained within the packaging, to utilise a new biopsy probe (12G) for the procedure. This action has been closed-out on 10/05/2017.

Device

Bard EnCor Needle Guide Insert (part of the EnCor Breast Biopsy Probe)
  • Modèle / numéro de série
    Bard EnCor Needle Guide Insert (part of the EnCor Breast Biopsy Probe)Item Code: ENCFINSERT10GMultiple Lot numbers affectedARTG Number: 153519
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd