Events

Central venous catheters: various pressure injectable, multi-lumen and multi-lumen with Arrowg+ard® antimicrobial surface 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/2014/022
  • 사례 연번
    CON425126
  • 날짜
    2014-06-12
  • 사례 출판 날짜
    2014-06-12
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON425126?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 field safety notice (fsn) dated 15 may 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 affected stock using Appendix 1 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 Field Safety Notice (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. MHRA is not proposing a recall or elective replacement of in situ catheters. Please make appropriate checks and ensure that lumens are used according to your organisation’s protocol.

Device

Central venous catheters: various pressure injectable, multi-lumen and multi-lumen with Arrowg+ar...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Central venous catheters: various pressure injectable, multi-lumen and multi-lumen with Arrowg+ard® antimicrobial surface. Specific product references and part numbers are affected. Check Appendix 1 of the FSN for the full list of 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 FSQ489 BR-10854 8.5FR x 11cm set plus 3 way tap and scalpel FSQ607 BR-12854 8.5FR x 16cm Hi Flo with stop cocks FSQ443 BR-15854 8.5FR x 20cm set plus 3 way tap and scalpel FSQ965 BR-20854 8.5FR x 11cm Quad lumen antimicrobal CVC with 3 way stopcock FSQ609 BR-22854 8.5FR x 16cm anti-microbial Arrow Gard blue mid range set with stop cocks FSQ611 BR-25854 8.5FR x 20cm anti-microbial Arrow Gard blue mid range set with stop cocks FSQ599 CK-15854E 8.5FR x 20cm comprehensive pack FSQ545 CS-12854-E 8.5FR x 16cm set with Raulerson syringe FSQ444 CS-14854-E 8.5FR x 30cm set with Raulerson syringe FSQ1458 CS-15854-E 8.5FR x 20cm Quad-lumen central venous catheterization set with blue flextip catheter FSQ447 CS-22854-E 8.5FR x 16cm set with Raulerson syringe and Arrowgard plus blue antimicrobial surface treatment FSQ448 CS-25854-E 8.5FR x 20cm set with Raulerson syringe and Arrowgard plus blue antimicrobial surface treatment FSQ1461 CS-42854-E 8.5FR x 16cm 4 lumen central venous catheter with arrowg+ard blue plus antimicrobial technology. FSQ440 CV-12854 8.5FR x 16cm set FSQ441 CV-15854 8.5FR x 20cm set FSQ445 CV-22854 8.5FR x 16cm set with Arrowgard plus antimicrobial surface treatment FSQ446 CV-25854 8.5FR x 20cm set with Arrowgard plus antimicrobial surface treatment Northern Ireland: FVB000031 BR-15854 ARROW AKI BR-15854 4L CVC SET 8.5FR 20CM STOPCOCKS(5) FVB000024 BR-22854 ARROW AKI BR-22854 4L CVC SET AGB 8.5FR 16CM STOPCOCKS(5) FVB000025 BR-25854 ARROW AKI BR-25854 4L CVC SET AGB 8.5FR 20CM STOPCOCKS(5) FVB000028 CS-12854-E ARROW AKI CS-12854-E CATHETER QUAD LUMEN, 8.5FR, 16CM, WITHOUT COATING FVB000367 CS15854E ARROW AKI 4 LUMEN CVC SET ARS 8.5FR 20CM       (5) FVB000029 CS-15854-E ARROW AKI CS-15854-E CATHETER QUAD LUMEN, 8.5FR, 20CM, WITHOUT COATING FVB000022 CS-22854-E ARROW AKI CS-22854-E CATHETER QUAD LUMEN, 8.5FR, 16CM,WITH ARROW GUARD FVB000023 CS-25854-E ARROW AKI CS-25854-E CATHETER QUAD LUMEN, 8.5FR, 20CM,WITH ARROW GUARD FVB000026 CV22854SR ARROW ACW CV22854SR 4L CVC SET AGB 8.5FR 16CM ONC Scotland SKU: 028030 BR-12854 CVC SET:4 LUMEN 8.5 FR X 16CM 137954 CS-22854-E CVC SET:4 LUMEN 8.5 FR X 16CM 083053 CS-25854-E CVC SET:4 LUMEN 8.5 FR X 20CM 061693 CV-12854 CVC SET:4 LUMEN 8.5 FR X 16CM 091065 CV-22854 CVC SET:4 LUMEN 8.5 FR X 16CM Wales NSV: Manufacturer’s codes as in Appendix 1 of the FSN .
  • Manufacturer
    Arrow International (a division of Teleflex)

Manufacturer

Arrow International (a division of Teleflex)