Events

Spinocath G22 / G27 (Spinal anaesthesia kit) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 B Braun 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-2016-RN-01228-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-09-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01228-1
  • 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
    During internal quality checks b. braun discovered that the certain spinocath articles may have holes in the pvc film of the sterile barrier system. there is a risk that microorganisms may penetrate the sterile barrier through the holes in the pvc barrier. thus, contamination is possible and may pose a risk to the patient. the risk of a clinically significant infection has been assessed as low but cannot be excluded. to date no harm or any other adverse patient outcome associated with this issue has been reported.
  • 조치
    B. Braun is advising users to inspect stocks and destroy all units from the affected article code. Credit will be provided for all unused/destroyed stock. Records of previous patients should be reviewed and any potentially related infections reported to B. Braun.

Device

Spinocath G22 / G27 (Spinal anaesthesia kit)
  • 모델명 / 제조번호(시리얼번호)
    Spinocath G22 / G27 (Spinal anaesthesia kit)Article Number: 4517725All batches affectedARTG Number: 148912
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd