Events

Rappel de 2-Way Foley Catheters and 2-Way Council Tip Foley Catheters (used for urinary drainage)Distributed between June 2013 to June 2015

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-01254-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-22
  • 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-01254-1
  • 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
    Bmd has identified that the instructions for use (ifu) included with the affected products provide the incorrect inflation volume. the inflation volume provided on the catheter’s valve cap does state the correct inflation volume. the ifu contains a chart entitled recommended inflation volumes with incorrect volumes. the inflation volume provided on the catheters valve cap does state the correct inflation volume.If the user follows the ifu and under inflates the balloon, the patient may experience some form of urine bypass due to the poor seating of the balloon in the bladder.
  • Action
    Bard is providing users with the correct inflation volumes for the affected products. This action has been closed-out on 30/08/2016.

Device

2-Way Foley Catheters and 2-Way Council Tip Foley Catheters (used for urinary drainage)Distribute...
  • Modèle / numéro de série
    2-Way Foley Catheters and 2-Way Council Tip Foley Catheters (used for urinary drainage)Distributed between June 2013 to June 2015Multiple product and catalogue numbers affectedARTG Number: 158417
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd