Events

Rappel de SANGOFIX IV Administration Set and HEIDELBERG EXTENSION TUBING SANGOFIX IV Administration Set

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-2013-RN-01289-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-12-03
  • 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-2013-RN-01289-1
  • 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
    Following reports of leaking from the in-line safsite injection site, initial investigations have identified that on disconnection of a luer connector used to access the injection site, a resealing issue may occur intermittently. this may result in fluid leaking from the valve.
  • Action
    As an interim corrective action, B.Braun is recommending that end users fit a stand-alone Safsite valve to the in-line injection site. The valve can be used for injection or infusion and does not need to be removed. Further notifications will be undertaken if any additional actions are required based on B. Braun's investigations.

Device

SANGOFIX IV Administration Set and HEIDELBERG EXTENSION TUBING SANGOFIX IV Administration Set
  • Modèle / numéro de série
    SANGOFIX IV Administration Set and HEIDELBERG EXTENSION TUBING SANGOFIX IV Administration SetArticle code: 4050193Batch number: 3H24278T34ARTG Number: 137615HEIDELBERG EXTENSION TUBINGArticle code: 4052197 Batch number: 3H21278A23ARTG Number:139265
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd