Events

Safety Alert Or Field Safety Notices for TRACOE twist tracheostomy tubes

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by TRACOE Medical.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/063
  • Event Number
    CON303149
  • Date
    2013-08-13
  • Event Date Posted
    2013-08-13
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON303149?tabName=allTabs
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
  • Product Description
    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