Events

Multi Lumen and Pressure Injectable Central Venous Catheters 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Mayo Healthcare Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2014-RN-00613-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-06-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00613-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    There is a low level of occurrence (<0.02%) of the lumen exit and lumen size on the extension line being misprinted on central venous catheters (cvc). as an example, the distal lumen may be printed with the word 'medial 18 ga' instead of 'distal 16ga'. misprinted labelling can cause user dissatisfaction with flow rates (ml/hr) in the case the lumen would be expected to perform as labelled for high volume gravity infused (the mismarked 16ga lumen) since in reality this is an 18ga lumen and gravity flow is approximately half (1/2) the expected flow rate in ml/hr for a 16ga lumen. this could result in a worst case scenario clinical intervention to use a pressure bag or pump to achieve adequate flow rates. the colour coding of all hubs is correct and corresponds to the arrow system.
  • 조치
    Mayo Healthcare Pty Ltd is advising their customers to be aware of the incorrect labelling.

Device

Multi Lumen and Pressure Injectable Central Venous Catheters
  • 모델명 / 제조번호(시리얼번호)
    Multi Lumen and Pressure Injectable Central Venous CathetersAffected Lot Numbers: 71F14A0329, RF1082062, 71F13H0637, ZF3063390, 71F14C0868, ZF1124891, ZF3051182, 71F13K0810, 71F13J1589, 71F14C0173, ZF2052625, 71F13H0972, 71F13K1389, 71F13K1796, 71F13K0429, ZF2111681, 71F13H1291, 71F13L0166, 71F14A0120, 71F13K1808, 71F14A1404, 71F13K0325, 71F13L1212, 71F14B0386, ZF3052590, RF0127942, 71F13K1625, ZF2123457, 71F14B0029, RF1069981, RF0087867, ZF3040526, 71F14B0377 ARTG Number: 142543
  • Manufacturer
    Mayo Healthcare Pty Ltd

Manufacturer

Mayo Healthcare Pty Ltd