Events

Recall of Beckton Dickinson Vacutainer Multiple Sample Luer Adaptor

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by BD Medical (USA).

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    14561
  • Event Initiated Date
    2013-04-26
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Becton Dickinson Ltd, 14B George Bourke Drive, Mt Wellington, Auckland 1060
  • Reason
    Manufacturer has received a number of complaints relating to blood leakage when the bd vacutainer multile sample luer adapter is used in the blood collection process. these complaints relate to:, 1. the sleeve covering the np cannula, 2.Luer tip damage., due to current stocks holdings both locally and globally and existing demands bd is unable to substitute product for the bd vacutainer multiple sample luer adapter. should a defective device be used bd is providing information (product correction ) regarding the use of the device ., bd recommends that staff closley observe the luer tip of the device for potential damage. in the event that damage is observed staff are instructed to discard the individual device. should blood leak from the luer connection during blood collection ases the need to conduct a re-draw with a new luer adaptor, based upn the volume of blood in the tube.
  • Action
    Manufacturer to issue advice regarding use

Device

Beckton Dickinson Vacutainer Multiple Sample Luer Adaptor
  • Model / Serial
    Model: 367300, Affected: all lot numbers manufactured starting with lot number 1354918 and after
  • Manufacturer
    BD Medical (USA)

Manufacturer

BD Medical (USA)