Events

Bard EnCor Needle Guide Insert (part of the EnCor Breast Biopsy Probe) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bard 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-01101-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-08-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01101-1
  • 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
    Bard peripheral vascular has identified that the affected lot numbers may be at risk of having an incorrect encor accessory needle guide insert. specifically, a smaller diameter (12g) insert may be contained within the larger (10g) package. this will render the device unusable and the user will need to replace the incorrect needle guide with one of the correct size. to date, bard have received 6 complaints from customers that have received the smaller product in error; none have resulted in an adverse event to patient or loss of functionality of the encor probe.
  • 조치
    Bard is advising users that if the incorrect Needle Guide Insert is contained within the packaging, to utilise a new biopsy probe (12G) for the procedure. This action has been closed-out on 10/05/2017.

Device

Bard EnCor Needle Guide Insert (part of the EnCor Breast Biopsy Probe)
  • 모델명 / 제조번호(시리얼번호)
    Bard EnCor Needle Guide Insert (part of the EnCor Breast Biopsy Probe)Item Code: ENCFINSERT10GMultiple Lot numbers affectedARTG Number: 153519
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd