Events

Steel cannula infusion sets 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Unomedical a/s 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 연번
    MDA/2015/027
  • 날짜
    2015-07-23
  • 사례 출판 날짜
    2015-07-23
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/steel-cannula-infusion-sets-risk-of-needle-breaking-in-use
  • 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
    Unomedical a/s issued an FSN in May 2015 to distributors but does not know where all the sets were sent.
  • 원인
    (unomedical a/s) may cause leakage of medication and require surgical intervention to remove the needle (mda/2015/027).
  • 조치
    Ensure all users are aware of the potential for the set’s needle to break (see field safety notice (FSN) for details of affected sets). Ensure procedures are in place for all users, including patients, to: check the infusion sets prior to use and do not use sets with bent or damaged needles remove sets carefully and check that they are intact after use receive and understand the instructions for use contact a health care provider for clinical assessment if a needle has broken

Device

Steel cannula infusion sets
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    The following steel cannula infusion sets are affected:SURE-T SURE-T Paradigm contact detach contact Sub Q neria neria detach neria multi thalasetFurther device details including lot numbers and item numbers are in the manufacturer’s FSN.
  • Manufacturer
    Unomedical a/s

Manufacturer

Unomedical a/s
  • 제조사 주소
    Cindie Vandfeldt Telephone: +45 4642 7880Email: FSCA-ID@convatec.com
  • 제조사 모회사 (2017)
    Triona Holding Sa
  • Source
    MHRA