Events

Rappel de VACUTAINER BRAND PRESET KIT

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
    20295
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-12-29
  • 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 reports of safety cover disengagement and needlestick injury (nsi) for the bd eclipse needle. based on the customer reports in some cases when the safety cover is pushed over the needle it disengages resulting in an exposed needle which can increase the risk of nsi. some customer reports indicate an audible "click" sound before the safety cover is locked (activated) followed by a second "click" sound when the safety cover is locked over the needle. this may potentially increase the risk of nsi if the user assumes the safety cover is locked after the initial "click". bd advises customers to be aware of this matter and follow the instructions for use (ifu) to: "center your thumb or forefinger on the textured finger pad and push the safety cover forward over the needle until you hear or feel it lock. visually confirm that the needle is covered.".

Device

VACUTAINER BRAND PRESET KIT
  • Modèle / numéro de série
    Model Catalog: 364390 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 364391 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305786 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305785 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305784 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305783 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305782 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305781 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305780 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305779 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305778 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305768 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305767 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305766 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305765 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305764 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305763 (Lot serial: >10 NUMBERS
  • Description du dispositif
    BD ECLIPSE NEEDLE (DEVICE LICENCE #788);BD ECLIPSE NEEDLE (DEVICE LICENCE #61367)
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.