Events

Rappel de PhaSeal Secondary Set (C61)

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-2018-RN-00834-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-06-25
  • 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-2018-RN-00834-1
  • 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
    Becton dickinson (bd) has received reports of leakage which could result in the potential exposure of hazardous drugs to the healthcare worker during preparation, transport or administration.This defect was noted by customers during product use. leakage was observed between the connector to the secondary set spike and the tubing to the spike joint. the defect cannot be detected by visual inspection only. 8 reports relating to this issue have been received in australia. to date, no reports of injury have been received in australia.
  • Action
    BD is advising customers to immediately review inventory and quarantine affected product. BD will arrange collection of affected stock from facilities.

Device

PhaSeal Secondary Set (C61)
  • Modèle / numéro de série
    PhaSeal Secondary Set (C61) Product code: 515302 Lot Number: 1005467 Distributed between 3/11/17 - 23/04/18ARTG Number: 299777(Becton Dickinson Pty Ltd - Basic intravenous administration set)
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd