Events

Frazier suction handle 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 ConvaTec Australia 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-2018-RN-00061-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-01-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00061-1
  • 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
    Convatec has been made aware of overseas complaints from users regarding swivelling of the suction tip of the handle of these devices. depending on the type of procedure, there is a potential for serious harm such as delayed recovery/delay in treatment, and tissue damage. it is very likely that the user may still be able to continue suctioning even after the suction tip starts to swivel within the handle. the chances of detecting the swivel by the user remain high.No complaints for this issue have been received to date in australia. no patient harm has been reported as a result of this issue.
  • 조치
    Convatec is advising users to inspect the Frazier suction handle for a loose tip prior to use. Additional/alternative Frazier units may be kept on standby just in case users experience swivelling of the suction tip. The manufacturer is currently validating a revised manufacturing process after shifting the bending fulcrum of the bending fixture from the handle to the metal tube thus reducing the impact of the bending force on the handle. After successful validation and product testing, the revised product will be introduced to the market.

Device

Frazier suction handle
  • 모델명 / 제조번호(시리얼번호)
    Frazier suction handleProduct code: UM1912 (12 Fr)Lot Number: CGCA06-01ARTG Number - 289102 (ConvaTec Australia Pty Ltd - Suction tip, general-purpose, single use)
  • Manufacturer
    ConvaTec Australia Pty Ltd

Manufacturer

ConvaTec Australia Pty Ltd