Events

Safety Alert Or Field Safety Notices for BD Vacutainer multiple sample Luer adaptors catalogue number 367300

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Becton.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/075
  • Event Number
    CON326443
  • Date
    2013-10-16
  • Event Date Posted
    2013-10-16
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON326443?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Increased risk to users of exposure to blood, and a risk of under filling blood collection tubes which could lead to unexpected results in some laboratory tests.  this problem was first identified in may 2013 (see bd’s field safety notice and the mhra’s mda/2013/061).  bd has now identified that further lots are affected and has issued a second field safety notice providing full details of all affected lots.  bd has received reports where the retractable sleeve, which covers the non-patient cannula before and after a blood collection tube is filled, has either failed to recover on removal of the sample tube, leaked, or fallen off. reports have also been received of leakage at the luer tip connection.
  • Action
    Identify whether you have any of the lots that are affected and ensure that all relevant staff are aware of the recommended actions in the manufacturer’s new Field Safety Notice including: to continue the use of universal/standard precautions to ensure that filled blood collection tubes meet the required fill volume as indicated on the specific tube prior to processing. Contact BD for replacements of products from affected lots if a local risk assessment indicates this is necessary, or if this is preferred. Action by: All healthcare workers who use these devices or process blood samples, and those involved in their purchase, supply and distribution.

Device

BD Vacutainer multiple sample Luer adaptors catalogue number 367300
  • Model / Serial
  • Product Description
    Vacutainer® multiple sample Luer adaptor for blood sample collection. Specific lot numbers affected. All BD Vacutainer multiple sample Luer adaptors catalogue number 367300, NHS Supply Chain Code KFK036 (England only), which have a lot number that falls within the following numerical range (inclusive) are affected: Lot number 1326169 , expiry date 11/2014 to lot number 3072890 , expiry date 03/2016 Note : This does not affect any other BD products which have a lot number within this range.
  • Manufacturer
    Becton

Manufacturer

Becton