Events

Alerta De Seguridad O Notificaciones De Seguridad para Primary PlumSet Clave secondary port

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 Hospira.

¿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/2013/079
  • Número del evento
    CON335060
  • Fecha de publicación del evento
    2013-11-13
  • 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/CON335060?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 interruption to iv therapy, which may require medical intervention. this is due to leakage of fluids from the break in the bond between the clave needle-free connector and the secondary port of the plumset.  hospira issued a field safety notice (fsn) dated 8 august 2013 to advise users how to minimise the possibility of breakage, but has not received confirmation from enough users that they have received and acted on this information.
  • Acción
    Identify affected administration sets. Ensure that all users are aware of the recommendations given in the FSN. In particular, do not bend or twist the Clave needle-free connector when accessing the secondary port. Return the completed reply form to Hospira.

Device

Primary PlumSet Clave secondary port
  • Modelo / Serial
  • Descripción del producto
    Intravenous administration sets: Primary PlumSet Clave secondary port. Specific list numbers are affected. All lots manufactured after July 2007 of the following list numbers have been supplied to the UK and are affected: 140010728 140018328 140019228 140149228 142129228 196735324 Note that any other list numbers detailed in the FSN have not been supplied to the UK
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    MHRA