Events

Alerta De Seguridad O Notificaciones De Seguridad para Central Venous Catheters: Multicath Expert 5 Lumen (9.5FG/16cm)

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 Vygon.

¿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/2014/045
  • Número del evento
    CON482907
  • Fecha
    2014-12-05
  • Fecha de publicación del evento
    2014-12-05
  • 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/CON482907?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 incorrect placement of catheter and delay to treatment. this is due to a manufacturing problem resulting in: decreased length of the catheter. the catheter tip may not reach the desired position during placement. catheters with four lumens (instead of five). this may then require additional catheter or extension sets after placement. vygon has issued a field safety notice (fsn), dated 16 september 2014, to its customers recalling affected catheters but has not received enough replies to assure themselves that users have received and acted on this information.
  • Acción
    Identify and quarantine affected catheters. Complete the confirmation form in the FSN to arrange for replacement catheters if necessary. Return the form to the manufacturer. All those responsible for the purchase and use of this device.

Device

Central Venous Catheters: Multicath Expert 5 Lumen (9.5FG/16cm)
  • Modelo / Serial
  • Descripción del producto
    Central Venous Catheters: Multicath Expert 5 Lumen (9.5FG/16cm). Product Code: 8159.167 Lot/Batch number: 020414GE If relevant to you, the national supply codes are as follows: England NPC: FSU144 . Northern Ireland: Device supplied by PaLS as a 'Non Stock Item' Scotland SKU: NP106/12 Wales NSV: FSX0677
  • Manufacturer
    Vygon

Manufacturer

Vygon