Events

Alerta De Seguridad O Notificaciones De Seguridad para BD Vacutainer multiple sample Luer adaptors catalogue number 367300

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/2013/075
  • Número del evento
    CON326443
  • Fecha
    2013-10-16
  • Fecha de publicación del evento
    2013-10-16
  • 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/CON326443?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 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.
  • Acción
    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
  • Modelo / Serial
  • Descripción del producto
    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