Events

Secondary Set Oncology 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 CareFusion Australia 316 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-2017-RN-00465-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-04-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00465-1
  • 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, becton dickenson (bd) has received reports of cracking of the secondary set back check valve male luer resulting in leaking of the infusion fluid. during use of the set, a leak occurs at the connection between the needle free valve and back check valve (bcv) connection. leakages can cause delay of infusion, interruption of infusion, exposure to infusates, or under-infusion. bd has not received any reports of serious injury or death associated with the separation or leaks. bd is not aware of any report of injury attributed to this defect in australia.
  • 조치
    BD is advising users to discontinue use of and segregate the identified units, and then return to BD. Replacement stock or credit will be provided.

Device

Secondary Set Oncology
  • 모델명 / 제조번호(시리얼번호)
    Secondary Set Oncology Catalogue Number: 72951NE Lot Numbers: 1000089, 1000129, 1000208, 1000468, 1000469, 1000687 and 1000713ARTG Number: 125916
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd