Events

BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder 21G & 22G.21G 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Becton Dickinson 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-2015-RN-00728-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-08-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00728-1
  • 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
    Bd has become aware that some lots of the bd vacutainer eclipse signal blood collection needle with integrated holder (catalogue numbers 368835 and 368836) have the potential for the integrated holder to become detached from the needle. this detachment can lead to possible sample collection failure, and in exceptional circumstances, have the potential to cause a needle stick injury. the manufacturer has estimated that the frequency of this failure mode is 0.198%.
  • 조치
    BD is providing instructions to allow the continued use the Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder: - Prior to use, ensure that the pink Eclipse Shield is positioned over the green or black needle cover. Grasp the needle cover and pink Eclipse Shield together and the holder in the other hand and pressing firmly down on the pink Eclipse Shield pull in a straight direction. Do not bend the device whilst pulling. - If the holder becomes detached, dispose of the device in an appropriate sharps collector. This action has been closed-out on 17/08/2016.

Device

BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder 21G & 22G.21G
  • 모델명 / 제조번호(시리얼번호)
    BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder 21G & 22G.21GCatalogue Number : 368835 Lot/Batch Numbers4302105 4266252 4302106 4276343 4346490 4344023 4252010 5041109 4259413 5072433 22G Catalogue Number :368836 Lot/Batch Numbers 4268488 4346068 4302103 5027368 4346062ARTG Number: 128397
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd