Events

Alerte Ou Avis De Sécurité sur BD Vacutainer multiple sample Luer adaptors catalogue number 367300

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Becton.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2013/075
  • Numéro de l'événement
    CON326443
  • Date
    2013-10-16
  • Date de publication de l'événement
    2013-10-16
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON326443?tabName=allTabs
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    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