Events

Rappel de EPILOR SYRINGE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BECTON DICKINSON CANADA INC..

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
    100551
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-09-06
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Bd has received several reports indicating that the plunger of the 7 ml bd epilor plastic bd luer-lok loss of resistance syringe (lor) may stall or stick when travelling within the syringe. this may prevent the user from detecting a loss of resistance upon entering the epidural space. if this occurs the user may continue to advance the syringe and needle through the epidural space and the dura into the spinal canal/intrathecal space resulting in a spinal anesthesia instead of an epidural anesthesia. there have been no reports of harm to patients. date the event was first identified: 06/19/2013. bd has received complaints from customers indicating that product has exhibited higher than normal resistance in the 7ml epilor syringe. there have been a total of 7 complaints for related events in the last 3 fiscal years.

Device

EPILOR SYRINGE
  • Modèle / numéro de série
    Model Catalog: 405198 (Lot serial: >10 contact manufacturer); Model Catalog: 405291 (Lot serial: >10 contact manufacturer); Model Catalog: 406078 (Lot serial: >10 contact manufacturer)
  • Description du dispositif
    7 mL BD Epilor plastic BD Luer-Lok LOR Syringe (Bulk non-sterile & sterile single use)
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.