Events

Retiro De Equipo (Recall) de VACUTAINER BRAND PRESET KIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECTON DICKINSON CANADA INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    20295
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-12-29
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    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
  • Descripción del producto
    BD ECLIPSE NEEDLE (DEVICE LICENCE #788);BD ECLIPSE NEEDLE (DEVICE LICENCE #61367)
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.