Events

Alerta De Seguridad O Notificaciones De Seguridad para BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes

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 Dickinson.

¿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
  • Fecha
    2018-04-26
  • Fecha de publicación del evento
    2018-04-26
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/bd-vacutainer-edta-bd-vacutainer-lithium-heparin-tubes-risk-of-incorrect-results-for-lead-testing-or-other-assays-using-asv-methodology
  • 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
    BD have published a Field Safety Notice to advise users to discontinue lead testing with affected devices when using assays with ASV methodology, known to be used within the Magellan LeadCare® testing systems, or any other assay employing ASV methodology.BD have identified that Thiuram, a chemical in the rubber tube stopper may release sulfur gases which bind to the lead particles in the blood sample making it difficult to detect the correct amount of lead in the sample and may give false low results when using ASV methodology, used in Magellan Diagnostics’ LeadCare® Testing Systems, and other assays.BD have undertaken a programme of testing to identify if any other assays are affected by the issue identified. To date no other assays have been noted to be affected. Revised instructions for use will be made available for users to download by the 8th May 2018.
  • Causa
    Manufactured by becton dickinson (bd) – due to a material in the rubber stopper, affected blood collection tubes may not be compatible with assays using anodic stripping voltammetry (asv) methodology.
  • Acción
    Identify affected devices, which are listed in the manufacturer’s Field Safety Notice (FSN). Discontinue lead testing with affected devices when using assays with ASV methodology, known to be used within the Magellan LeadCare® testing systems, or any other assay employing ASV methodology. There is no requirement for customers to return affected devices to BD. Review previous lead test results which were performed using Magellan LeadCare® instrumentation or any other assay employing ASV methodology. Lead testing using Graphite furnace atomic absorption spectroscopy (GFAAS) coupled with ICP-MS are not affected by this issue and can be performed as normal with BD Vacutainer® EDTA and BD Vacutainer® Lithium Heparin tubes. If any adverse events occur relating to these products, please report these to MHRA via YellowCard or the relevant devolved administrations (Scotland, Wales and Northern Ireland).

Device

BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes
  • Modelo / Serial
  • Descripción del producto
    Becton Dickinson: BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes
  • Manufacturer
    Becton Dickinson

Manufacturer

Becton Dickinson