Events

Rappel de BD Q-Syte Luer Access Split Septum Device(Connector designed to allow access to injection sites for delivery of medication)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Becton Dickinson 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-00161-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-02-26
  • 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-00161-1
  • 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
    Some units have an off-centred slit in the silicon septum resulting in a thinner column wall. when actuated, units with a thinner column wall may tear leading to leakage of infusate/medication or blood from the side vent opening. in addition to leakage, the manufacturer has identified that there is a smallpotential risk for air to enter the bloodstream which could result in air embolism.
  • Action
    Customers are advised to discontinue use of and immediately quarantine any of the affected stock. This action has been closed-out on 09/08/2016.

Device

BD Q-Syte Luer Access Split Septum Device(Connector designed to allow access to injection sites f...

Manufacturer

Becton Dickinson Pty Ltd