Events

Rappel de Spinocath G22 / G27 (Spinal anaesthesia kit)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par B Braun 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-01228-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-09-21
  • 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-2016-RN-01228-1
  • 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
    During internal quality checks b. braun discovered that the certain spinocath articles may have holes in the pvc film of the sterile barrier system. there is a risk that microorganisms may penetrate the sterile barrier through the holes in the pvc barrier. thus, contamination is possible and may pose a risk to the patient. the risk of a clinically significant infection has been assessed as low but cannot be excluded. to date no harm or any other adverse patient outcome associated with this issue has been reported.
  • Action
    B. Braun is advising users to inspect stocks and destroy all units from the affected article code. Credit will be provided for all unused/destroyed stock. Records of previous patients should be reviewed and any potentially related infections reported to B. Braun.

Device

Spinocath G22 / G27 (Spinal anaesthesia kit)
  • Modèle / numéro de série
    Spinocath G22 / G27 (Spinal anaesthesia kit)Article Number: 4517725All batches affectedARTG Number: 148912
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd