Events

Alerte Ou Avis De Sécurité sur unkown device

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 manufacturer #17429.

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/2012/009
  • Numéro de l'événement
    CON143805
  • Date
    2012-03-01
  • Date de publication de l'événement
    2012-03-01
  • 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/CON143805?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
    Smiths medical has become aware of an increase in the number of reports of disconnections of the luer lock connector at the patient end of the tubing for these fluid warming sets. this can lead to a risk of fluid/ blood loss or delay in therapy. the mhra cannot be confident that these recalls have been effective and that users have received and acted on the information provided in the manufacturer’s field safety notices (fsns).
  • Action
    Do not use the affected devices. Contact Smiths Medical to arrange the return and replacement of the affected sets as advised in the two Smiths Medical Field Safety Notices (FSNs) issued on 28 November 2011 for: Level 1® Hotline®         The FSNs list the lot numbers of all affected devices. Send the confirmation return form to Smiths Medical. Action by All those involved in the supply and use of these devices.

Device

unkown device

Manufacturer

manufacturer #17429