Notificaciones De Seguridad De Campo acerca de BD Plastipak / Oral Syringes

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 Becton Dickinson UK Limited.

¿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
  • Fecha
    2016-11-16
  • País del evento
  • 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 communicated in september 2015, via an urgent field safety notice (mss-15-637 fa) that customers had reported reduced potency of certain medications when stored in bd plastic disposable syringes, made with a stopper provided by an alternate supplier. the purpose of this follow-up is to inform our customers about the corrective actions implemented by bd: 1- all syringes currently distributed in ireland by bd are manufactured with a stopper provided by our primary supplier (not affected by the issue), except for the 4 products listed in table a. 2- the syringes in table a are currently manufactured with the stopper from the alternate supplier and are still in distribution in ireland. 3- bd is committed to converting all syringes sold in the eu back to the primary stopper supplier and expects that from july 2017, all syringes supplied to the marketplace will contain the primary stopper only. .

Device

Manufacturer