Events

Rappel de Atrium Trocar Catheters, Sizes 8Fr to 32FrProduct Code Numbers: 8408, 8410, 8412, 8416, 8420, 8424, 8428, 8432

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Maquet 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-01419-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-02
  • 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-01419-1
  • 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
    It has been identified that atrium trocar catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. this graphical icon shows there are 6 side holes on the trocar catheter; however, the correct number of eyelets on the trocar catheter is 2 side holes.To date, atrium has received two complaints of insufficient drainage, with injury, as a result of selecting trocar catheters that had fewer eyelets than displayed on the product label. although the use of a trocar catheter with two eyelets may be effective in most patients, the potential risks related to use of the trocar catheter with 2 eyelets are: incomplete drainage of pleural effusion or pneumothorax, the need for repeat chest tube or pleural drain insertion, and surgical site infection.
  • Action
    Maquet is advising customers to remove affected product from supply/inventory and place in quarantine. All sterile and un-used affected products are to be returned to Maquet for credit. Replacement product is not available as all Trocar Catheters have been discontinued however Maquet is providing information to customers about substitute product from alternative suppliers. This action has been closed-out on 25/05/2017.

Device

Atrium Trocar Catheters, Sizes 8Fr to 32FrProduct Code Numbers: 8408, 8410, 8412, 8416, 8420, 842...
  • Modèle / numéro de série
    Atrium Trocar Catheters, Sizes 8Fr to 32FrProduct Code Numbers: 8408, 8410, 8412, 8416, 8420, 8424, 8428, 8432All lot numbersARTG Number: 97358
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA