Events

Recall of BD Vacutainer Multiple Sample Luer Adapter

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Becton Dickinson Pty Ltd.

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
    RC-2013-RN-00335-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00335-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Bd has received a number of following complaints relating to blood leakage when the vacutainer adapter is used in the blood collection process:1)the sleeve covering the np cannula - non-sleeve recovery, sleeve leakage, and sleeve fall off (pop-off). should such an event occur, there is an increased likelihood of blood leakage into the tube holder when a blood collection tube is removed from the tube holder (i.E. the sleeve fails to re-cover the np cannula allowing blood to leak into the tube holder). bd estimates that approximately 1.47% of the devices will be impacted by this issue.2)luer tip damage – small “nicks” or “flash” have been observed on the luer tip that connects to needles, blood collection sets, and infusion sets. should such a damaged device be used, there is an increased likelihood of blood leakage from the connection between the vacutainer adapter r and the access device. bd estimates that less than 1% of the devices will be impacted by this issue.
  • Action
    BD is requesting customers to consider the risk of using a defective device in relation to their ability to maintain necessary blood collection procedures without the use of the BD Vacutainer Multiple Sample Luer Adapter. Should the customers choose to continue using the BD Vacutainer Multiple Sample Luer Adapter, BD is asking to ensure that all relevant staff are aware of the potential defects. BD also recommends that staff closely observe the luer tip of the device for potential damage. In the event that damage is observed, please instruct staff to discard the individual device. Should blood leak from the luer connection during blood collection please assess the need to conduct a re-draw, with a new luer adaptor, based upon the volume of blood within the tube (i.e. a low volume draw would require a re-draw). This action has been closed-out on 18/02/2016.

Device

BD Vacutainer Multiple Sample Luer Adapter
  • Model / Serial
    BD Vacutainer Multiple Sample Luer AdapterRef. No.: 367300All lot numbers manufactured starting with lot number 1354918 and afterARTG: 122153
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd