Events

Alerte Ou Avis De Sécurité sur Primary PlumSet Clave secondary port

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Hospira.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2013/079
  • Numéro de l'événement
    CON335060
  • Date de publication de l'événement
    2013-11-13
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON335060?tabName=allTabs
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
  • Description du dispositif
    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
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    MHRA