Events

Procedure packs containing various central venous catheters: pressure injectable, multi-lumen and multi-lumen with Arrowg+ard 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 (a division of Teleflex) 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/2014/028
  • 사례 연번
    CON435784
  • 날짜
    2014-07-11
  • 사례 출판 날짜
    2014-07-11
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON435784?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 incorrect lumen selection. the extension lumen may have the wrong exit (proximal, medial, distal) and size printed on it, although the hub colour coding remains correct. for example the distal lumen may be printed with the words ‘medial 18 ga’ instead of ‘distal 16ga’. arrow international issued a second field safety notice (fsn) dated 20 june 2014, which informed users of an extension to their original fsn dated 15 may 2014. this extension now includes affected devices in procedure packs. this medical device alert is an update to mda/2014/022 issued on 12 june 2014. clinicians and nursing staff may rely on the printed information on the catheter lumens to identify them and to select the appropriate lumen to deliver blood and other fluids. misprinted lumens could lead to a range of problems, if used inappropriately.
  • 조치
    Identify all additional affected stock using Appendix 2 of the FSN. NHS supply chain codes are detailed below. Ensure that all relevant clinicians and nursing staff are aware of this issue and receive a copy of the Arrow International second FSN. Be guided by Arrow’s hub colour coding, not by what is printed on the lumen. Arrow’s hub colour coding is: White = proximal lumen = 18 GA Grey = medial lumen 1 = 14 GA Blue = medial lumen 2 = 18 GA Brown = distal lumen = 16 GA Report any cases of misprinted lumens to MHRA.

Device

Procedure packs containing various central venous catheters: pressure injectable, multi-lumen and...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Update to MDA/2014/022 . Procedure packs containing various central venous catheters: pressure injectable, multi-lumen and multi-lumen with Arrowg+ard ® antimicrobial surface. Specific product references and part numbers are affected. Check Appendix 2 of the FSN for the full list of additional affected product codes. If relevant to you, the national supply codes are as follows: England NPC: NHS Supply chain code Manufacturer’s part number Product description FSQ1653 AR12854-MRI Manchester 4L CVC INS Pack 8.5Fr x 16cm FSQ1311 AR22854-HCH HCH 4L AGB CVC PACK 8.5FR 16CM FSQ372 AR22854-INSP INSP 16CM 4L AGB ARS CVC PACK FSQ1654 AR22854-MRI MANCHESTER ROYAL INFIRMARY AGBQUAD Northern Ireland: Manufacturer’s codes as in Appendix 2 of the FSN . Scotland SKU: Manufacturer’s codes as in Appendix 2 of the FSN . Wales NSV: Manufacturer’s codes as in Appendix 2 of the FSN .
  • Manufacturer
    Arrow International (a division of Teleflex)

Manufacturer

Arrow International (a division of Teleflex)