Events

Alerte Ou Avis De Sécurité sur TRACOE twist tracheostomy tubes

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 TRACOE Medical.

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/2013/063
  • Numéro de l'événement
    CON303149
  • Date
    2013-08-13
  • Date de publication de l'événement
    2013-08-13
  • 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/CON303149?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 delay in treatment. difficulty changing the inner cannula as the locking system can be too tight.
  • Action
    Identify the affected devices. Follow the advice in the TRACOE Field Safety Notice dated 7 August 2013 and in particular: Check the lock of the inner cannula before use to ensure it fits correctly e.g. not too tight. If too tight, attempt to lock and unlock 3 times. If it remains too tight use a different tube

Device

TRACOE twist tracheostomy tubes
  • Modèle / numéro de série
  • Description du dispositif
    TRACOE twist tracheostomy tubes. Various catalogue numbers. Distributed in the UK by Kapitex Healthcare Ltd. Affected tubes have a manufacturing date from 12/2012 to 06/2013. Catalogue numbers: TRACOE twist tracheostomy tubes REF 301, 302, 303, 304, 305, 306, 888-306, and 309. TRACOE twist spare inner cannulas REF 501 (-X), REF 503, REF 506 (-X). TRACOE twist tracheostomy tubes with low pressure cuff and atraumatic inserter REF 301-P, REF 302-P, REF 306-P, REF 888-306-P. TRACOE experc Set twist REF 320, REF321, Ref 322, and REF 888-322. Please note this only applies to the TRACOE twist range of products and does not apply to the TRACOE twist plus range.
  • Manufacturer
    TRACOE Medical

Manufacturer

TRACOE Medical