Events

Alerta De Seguridad O Notificaciones De Seguridad para Steel cannula infusion sets

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 Unomedical a/s.

¿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
  • Número del evento
    MDA/2015/027
  • Fecha
    2015-07-23
  • Fecha de publicación del evento
    2015-07-23
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/steel-cannula-infusion-sets-risk-of-needle-breaking-in-use
  • 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
    Unomedical a/s issued an FSN in May 2015 to distributors but does not know where all the sets were sent.
  • Causa
    (unomedical a/s) may cause leakage of medication and require surgical intervention to remove the needle (mda/2015/027).
  • Acción
    Ensure all users are aware of the potential for the set’s needle to break (see field safety notice (FSN) for details of affected sets). Ensure procedures are in place for all users, including patients, to: check the infusion sets prior to use and do not use sets with bent or damaged needles remove sets carefully and check that they are intact after use receive and understand the instructions for use contact a health care provider for clinical assessment if a needle has broken

Device

Steel cannula infusion sets
  • Modelo / Serial
  • Descripción del producto
    The following steel cannula infusion sets are affected:SURE-T SURE-T Paradigm contact detach contact Sub Q neria neria detach neria multi thalasetFurther device details including lot numbers and item numbers are in the manufacturer’s FSN.
  • Manufacturer
    Unomedical a/s

Manufacturer

Unomedical a/s
  • Dirección del fabricante
    Cindie Vandfeldt Telephone: +45 4642 7880Email: FSCA-ID@convatec.com
  • Empresa matriz del fabricante (2017)
    Triona Holding Sa
  • Source
    MHRA