Events

Notificaciones De Seguridad De Campo acerca de BD Plastipak™ Syringe, Catheter tip with Luer slip adaptor

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por BD.

¿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
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Bd is conducting a voluntary field safety corrective action for all lots of bd 100ml plastipak catheter tip (ct) syringe labeled with a 5yr expiration date. the syringes are being recalled due to leakage past stopper failures during internal routine real time stability tests, with failures beginning at the 2yr time point. no adverse event has been reported for this issue at this time. although the product can safely be used for 18 months after manufacturing, to avoid mistakes, we are recalling all lots labelled with a shelf life of 5 years. all affected lots are listed in table a below. users should stop using these lots immediately. .

Device

BD Plastipak™ Syringe, Catheter tip with Luer slip adaptor
  • Modelo / Serial
  • Manufacturer
    BD

Manufacturer

BD