Events

Notificaciones De Seguridad De Campo acerca de MINISEND-LUER LOCK CAP

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Sendal S.L..

¿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
  • Número del evento
    SN201401
  • Fecha
    2014-02-11
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/minisend-luer-lock-cap&id=3579f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    A potential fault has been identified with the sealing of the primary packaging (blister) of the minisend luer lock cap, leading to a possible loss of sterility of the product. not all units are affected, only those with a small sealing surface.  the manufacturer has confirmed that devices on the irish market, with product reference codes tp-mf and tp-mf-a are affected by this action. refer to attached field safety notice (fsn).
  • Acción
    Sendal S.L. requires that users check their inventory and quarantine all affected products/lots. In the absence of an alternative, it is recommended that users verify the integrity of the packaging and do not use units where the sealing appears defective.  Sendal requires that users return completed verification forms for this action to the Sendal representative.  The IMB recommends that users forward this safety notice to all those who need to be aware of this action within your organisation and to maintain awareness over this safety notice for an appropriate time period.

Device

MINISEND-LUER LOCK CAP
  • Modelo / Serial
  • Descripción del producto
    MINISEND-LUER LOCK CAP
  • Manufacturer
    Sendal S.L.

Manufacturer

Sendal S.L.