Events

Rappel de BD Epilor Plastic BD Luer-Lok Loss of Resistance (LOR) Syringe (7mL) (Used in conjunction with an epidural needle for identifying epidural space)

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-2013-RN-00922-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-09-06
  • 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-00922-1
  • 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
    Bd has received complaints relating to difficulty in moving the plunger rod or the plunger rod sticking. this has the potential to prevent the anaesthetist from correctly detecting the loss of resistance upon entering the epidural space.
  • Action
    Prior to using each syringe, it is recommended that anaesthetists ensure that there is no difficulty in moving the plunger rod and that the plunger rod does not stick. Any LOR Syringe that shows inappropriate resistance should be discarded; the procedure can then be continued by using another LOR Syringe that does not show resistance.

Device

BD Epilor Plastic BD Luer-Lok Loss of Resistance (LOR) Syringe (7mL) (Used in conjunction with an...
  • Modèle / numéro de série
    BD Epilor Plastic BD Luer-Lok Loss of Resistance (LOR) Syringe (7mL) (Used in conjunction with an epidural needle for identifying epidural space)Reference Number: 405291Lot Numbers: 0039440, 0154661, 0174905, 0252565, 1012200, 1124755, 1213029, 1312116, 1320204, 2286395, 2303141, 2334338, 2334339, 8277525, 8357843, 9093622 and 9149990ARTG Number: 120174
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd