Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Becton, Dickinson And Company.

¿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
    Recall / Field Safety Notice
  • ID del evento
    mdprc 133 05 18 000
  • Fecha de inicio del evento
    2018-05-30
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12689
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Bd states that it has received reports of users experiencing difficulty or failing to prime the above administration sets. the pump administration sets require priming before patient use as described in the directions for use. bd also states that it is during the priming process that this problem can be observed. during priming, when attempting to fill the drip chamber, the drops into the drip chamber will not be observed once the roller clamp is opened. bd further states that this problem is highly detectable.

Device

BD SmartSite Administration Sets
  • Modelo / Serial
    10015489, 11426965, 2120-0500, 2420-0007, 2420-0500
  • Descripción del producto
    Infusion Pump Administration Sets
  • Manufacturer
    Becton, Dickinson And Company

Manufacturer

Becton, Dickinson And Company