Events

Alerte Ou Avis De Sécurité sur Vacutainer® multiple sample Luer adaptor for blood sample collection

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/2013/061
  • Numéro de l'événement
    CON297580
  • Date
    2013-08-01
  • Date de publication de l'événement
    2013-08-01
  • 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/CON297580?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 underfilling of blood collection tubes which could lead to unexpected results in some laboratory tests. 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. bd has issued a field safety notice with advice to users, and will replace products from affected lot numbers on request.
  • Action
    Identify affected lots and ensure that all relevant staff are aware of the recommended actions in the manufacturer’s 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.

Device

Vacutainer® multiple sample Luer adaptor for blood sample collection
  • Modèle / numéro de série
  • Description du dispositif
    Vacutainer® multiple sample Luer adaptor for blood sample collection. Catalogue number 367300 (England only - NHS Supply Chain code KFK036). Specific lot numbers are affected. Affected lot numbers: 1333588 2123767 2249601 2289883 1333589 2213775 2249602 2297780 2024564 2213776 2255659 2305611 2051820 2222725 2282697 2314818 2061445 2226828 2282699 2108597 2242559 2289881
  • Manufacturer
    Becton

Manufacturer

Becton