Events

Rappel de Atrium Thoracic Catheters, Sizes 8Fr & 10Fr

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-2017-RN-00217-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-21
  • 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-00217-1
  • 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
    Current labelling on two models of atrium thoracic catheters requires clarification. for product code numbers 8008 (8fr thoracic catheter) and 8010 (10fr thoracic catheter), the graphical icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 fr and 10 fr thoracic catheters is two (2).To date, atrium has not received complaints as a result of selecting thoracic catheters that had fewer eyelets than displayed on the product label. although the use of a thoracic catheter with two eyelets may be effective in most patients, the potential risks related to use of the thoracic catheter with two eyelets are: incomplete drainage of pleural effusion or pneumothorax and/or the need for repeated chest tube or pleural drain insertion and/or surgical site infection.
  • Action
    The labelling will be updated for future production. In the interim, customers may continue to use the affected thoracic catheters with the current labelling, and are advised that correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2).

Device

Atrium Thoracic Catheters, Sizes 8Fr & 10Fr
  • Modèle / numéro de série
    Atrium Thoracic Catheters, Sizes 8Fr & 10FrProduct Code Numbers: 8008, 8010All Lot NumbersARTG Number: 97358
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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