Events

Alerta De Seguridad O Notificaciones De Seguridad para Portex® endotracheal tube holder (2.5mm and 3.0mm) sold as stand-alone products or packaged in intubation kits

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 Smiths Medical.

¿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
  • ID del evento
    MDA/2014/036
  • Número del evento
    CON456001
  • Fecha
    2014-09-17
  • Fecha de publicación del evento
    2014-09-17
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON456001?tabName=allTabs
  • 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
  • Causa
    Risk of extubation or delay to therapy as there may be difficulty passing a suction catheter through the endotracheal tube when the holder is locked. there may also be difficulty locking the holder. this is due to a manufacturing problem, which means the holder might compress the endotracheal tube. smiths medical has issued a field safety notice (fsn) recalling affected devices but hasn’t had sufficient confirmation that customers have received it and acted on it.
  • Acción
    Identify affected devices as described in the FSN and quarantine them. Complete and return the confirmation form in the FSN. Arrange for replacement devices with Smiths Medical.

Device

Portex® endotracheal tube holder (2.5mm and 3.0mm) sold as stand-alone products or packaged in in...
  • Modelo / Serial
  • Descripción del producto
    Portex® endotracheal tube holder (2.5mm and 3.0mm) sold as stand-alone products or packaged in intubation kits. Specific product codes and lot numbers. If relevant to you, the national supply codes are as follows: Scotland SKU: Smiths code NDC code H4001PS 054220 H4001S 007424 H4002PS 014408 H4002S 039364 H4051 - H4052 - England NPC: use manufacturer’s codes in the FSN Northern Ireland: use manufacturer’s codes in the FSN Wales NSV: use manufacturer’s codes in the FSN
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical