Events

TRACOE twist tracheostomy tubes 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 TRACOE Medical 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2013/063
  • 사례 연번
    CON303149
  • 날짜
    2013-08-13
  • 사례 출판 날짜
    2013-08-13
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON303149?tabName=allTabs
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    Risk of delay in treatment. difficulty changing the inner cannula as the locking system can be too tight.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    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