Events

Rappel de Bard Max-Core Disposable Core Biopsy Instrument Biopsy Gun Dispos MaxCore 14gx10cm Biopsy Gun Dispos MaxCore 16gx16cm Biopsy Gun Dispos MaxCore 18gx16cm Biopsy Gun Dispos MaxCore 18gx20cm ARTG Number: 174371

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-2017-RN-01238-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-10-03
  • 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-01238-1
  • 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, bard peripheral vascular has identified that specific product code / lot number combinations may be at risk of having issues related to proper functioning of the device. this includes difficulty with priming and firing, failure to obtain tissue sample, and in some instances self-activating after priming.In most cases, the identified issues (failure to prime, failure to fire, failure to obtain a sample) will lead to a varying degree of user dissatisfaction or may be associated with a prolonged procedure or minor tissue injury. although unlikely to lead to user or patient injury consistent with a serious adverse event, the unpredictable nature of self-activation presents some risk to use of the product. there is no residual risk to users or patients that used the product previously without incident.
  • Action
    1. Bard is advising users to inspect stock and quarantine any remaining units of the affected batches. 2. Affected stock can be returned to Bard.

Device

Bard Max-Core Disposable Core Biopsy Instrument Biopsy Gun Dispos MaxCore 14gx10cm Biopsy Gun Dis...
  • Modèle / numéro de série
    Bard Max-Core Disposable Core Biopsy InstrumentBiopsy Gun Dispos MaxCore 14gx10cmProduct Code: MC1410Lot Numbers: REBN2123, REBP1199 and REBP1807Biopsy Gun Dispos MaxCore 16gx16cmProduct Code: MC1616Lot Number: REBP1420Biopsy Gun Dispos MaxCore 18gx16cmProduct Code: MC1816Lot Number: REBN0342Biopsy Gun Dispos MaxCore 18gx20cmProduct Code: MC1820Lot Number: REBQ1014ARTG Number: 174371
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd