Events

Stopcocks (catalogue numbers W20058 and W21372) and specific products containing non-lipid resistant stopcocks 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Arrow® International 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/2009/047
  • 사례 연번
    CON052020
  • 사례 출판 날짜
    2009-07-27
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON052020?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 leakage or air embolism due to hub cracking at the female luer connector during delivery of infusions containing lipids.Teleflex medical has determined that the material used in the manufacture of these stopcocks is not lipid resistant and could be weakened during the administration of lipid solutions. these stopcocks, and the kits containing them, should be used only to administer non-lipid containing solutions. teleflex originally issued a field safety notice (fsn) in march 2009 that highlighted these risks. however, the sample product label in this fsn carried an extra warning not to use 70% isopropyl alcohol on the stopcocks. after further testing, teleflex has determined that these stopcocks (distributed in the united kingdom) can in fact be wiped with 70% isopropyl alcohol solutions without harmful effects. as a consequence, teleflex has now issued an amended fsn in july 2009 with a revised product label.This medical device alert has been issued due to the widespread use of these stopcocks and to ensure that all users are aware of this amended field safety corrective action.

Device

Stopcocks (catalogue numbers W20058 and W21372) and specific products containing non-lipid resist...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Stopcocks (catalogue numbers W20058 and W21372) and specific products containing non-lipid resistant stopcocks, manufactured by Arrow® The stopcocks are manufactured by Arrow® International, which is a subsidiary of Teleflex Medical. Product codes AH-05050-G, AI-07077-G, AH-05050-PU, AI-07077-PU (regardless of batch number) contain non-lipid resistant stopcocks.  Only product codes with batch numbers ZFxxxxxxx contain lipid resistant stop cocks. This is summarised in the table below: Product codes Lipid resistant batches Non-lipid resistant batches AH-05050-G None All AH-05050-PU AI-07077-G AI-07077-PU All product codes listed in Appendix A of the Field Safety Notice Lot numbers beginning with the letter ZF and followed by seven digits, e.g. ZFxxxxxxx. All other Lot numbers
  • Manufacturer
    Arrow® International

Manufacturer

Arrow® International