Events

Alerta De Seguridad O Notificaciones De Seguridad para Vacutainer® multiple sample Luer adaptor for blood sample collection

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Becton.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2013/061
  • Número del evento
    CON297580
  • Fecha
    2013-08-01
  • Fecha de publicación del evento
    2013-08-01
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON297580?tabName=allTabs
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
  • Descripción del producto
    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