Events

Epidural Minipack Systems (Epidural anaesthesia kit) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smiths Medical Australasia 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-2013-RN-01154-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-11-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01154-1
  • 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
    The manufacturer is updating the instructions for use (ifu) for users should they experience difficulties removing the catheter during procedure.The wording in the current ifu states: "if resistance is felt upon withdrawal, consult current medical literature for specific techniques". this is to be replaced by: "if resistance is felt or if the catheter stretches excessively on withdrawal, cease removal. never exert excessive force as this may compromise the integrity of the catheter. if clinically appropriate, reposition the patient (flex or extend, sit up or lay down) and slowly withdraw the catheter. if further resistance, repeat step and/or allow the patient to relax for several minutes/hours and attempt to remove later. if unable to remove, consult the anaesthetist. after removal, examine the catheter to ensure that the entire catheter with tip is intact. should the top not be intact, consult the anaesthetist".
  • 조치
    Smiths Medical is providing users with updated Instructions for Use (IFU) which includes the updated instructions.

Device

Epidural Minipack Systems (Epidural anaesthesia kit)
  • 모델명 / 제조번호(시리얼번호)
    Epidural Minipack Systems (Epidural anaesthesia kit)Product Number: 100/391/116ARTG Number: 167342
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd