Events

Rappel de BD NEXIVA CLOSED IV CATHETER SYSTEM - SINGLE PORT

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
    92404
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-04-03
  • 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
    Leaking septa have been observed in manufacturing and also in customer complaints. health canada requested on december 16 2013 that "all users of the product" be notified of the situation an "informal notification" a "level ill recall". date problem was firstidentified: april 30 2012 how the problem was identified: during routine in-process leak inspection of product during manufacture. customer complaints: observed increased complaint rate for leakage during april-june 2012.

Device

BD NEXIVA CLOSED IV CATHETER SYSTEM - SINGLE PORT
  • Modèle / numéro de série
    Model Catalog: 383512 (Lot serial: >10 numbers contact mfg); Model Catalog: 383516 (Lot serial: >10 numbers contact mfg); Model Catalog: 383517 (Lot serial: >10 numbers contact mfg); Model Catalog: 383519 (Lot serial: >10 numbers contact mfg); Model Catalog: 383532 (Lot serial: >10 numbers contact mfg); Model Catalog: 383536 (Lot serial: >10 numbers contact mfg); Model Catalog: 383537 (Lot serial: >10 numbers contact mfg); Model Catalog: 383539 (Lot serial: >10 numbers contact mfg); Model Catalog: 383540 (Lot serial: >10 numbers contact mfg); Model Catalog: 383591 (Lot serial: >10 numbers contact mfg); Model Catalog: 383594 (Lot serial: >10 numbers contact mfg)
  • Description du dispositif
    BD Nexiva Closed IV Catheter System - Single Port
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.