Events

Alerta De Seguridad O Notificaciones De Seguridad para Nasogastric feeding tubes – Ryles tubes (weighted tip)

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 Ltd.

¿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/2013/009
  • Número del evento
    CON239462
  • Fecha
    2013-02-26
  • Fecha de publicación del evento
    2013-02-26
  • 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/CON239462?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 the feeding tube due to incorrectly applied depth markings. despite issuing two field safety notices in january 2013, vygon ltd has not received sufficient confirmation from users that they have received and acted on this information.
  • Acción
    Identify and quarantine any affected devices. Ensure all users are aware of the manufacturer’s Field Safety Notices (dated 3 January 2013 and 21 January 2013). Return the confirmation requests in the FSNs to the manufacturer. If patients have affected tubes in situ, confirm correct placement before further use, following local protocols.

Device

Nasogastric feeding tubes – Ryles tubes (weighted tip)
  • Modelo / Serial
  • Descripción del producto
    Nasogastric feeding tubes – Ryles tubes (weighted tip). Size 12FG 125cm, product code: 392.12, lot number: 160412FG. Size 14FG 125cm, product code: 392.14, lot number: 100512FF. The affected product codes on the manufacturer’s website and device labels are specified as ‘392.12’ and ‘392.14‘.  The same products are referred to as ‘0392.12’ and ‘0392.14’ respectively in the manufacturer’s Field Safety Notices.
  • Manufacturer
    Vygon Ltd

Manufacturer

Vygon Ltd