Events

Alerta De Seguridad O Notificaciones De Seguridad para Flex connectors in Halyard Closed Suction 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 Halyard Health.

¿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
  • Fecha
    2018-09-19
  • Fecha de publicación del evento
    2018-09-19
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/flex-connectors-in-halyard-closed-suction-kits-risk-of-interruption-of-ventilation-mda-2018-030
  • 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
    The manufacturer found certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.If disconnection occurs during use, it will result in an open respiratory circuit and interrupt patient ventilation.
  • Causa
    Manufactured by halyard health – risk of some flex connectors in closed suction kits becoming loose or disconnecting, which may interrupt patient ventilation.
  • Acción
    Identify the affected devices as stated in the manufacturer’s Field Safety Notice (FSN). Ensure that all users receive the manufacturer’s FSN and that they understand the problem and actions to be taken. Refer to the FSN for actions to be taken. Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Device

Flex connectors in Halyard Closed Suction Kits

Manufacturer

Halyard Health
  • Dirección del fabricante
    Halyard Health Veronique PaulinTelephone +32 (2) 7112668Email: Veronique.Paulin@hyh.com or _EMEAFieldAction@hyh.com.
  • Empresa matriz del fabricante (2017)
    Halyard Health Inc
  • Source
    MHRA