Events

Plastic Cannula – 11 gauge 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-01163-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-09-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01163-1
  • 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
    Becton dickinson (bd) has identified punctures in the blister packaging detected during the packaging process for specific lots of plastic cannula – 11 gauge.A breach in the sterile barrier has the potential to render the device non-sterile. it is possible end users may not detect the pin holes, thus utilising impacted product clinically. this could result in harm to patients especially when immunocompromised.In association with this recall, bd has decided to discontinue catalogue number: 9391-0200.To date, bd is not aware of any report of injury attributed to this defect in australia.
  • 조치
    1. Users are to discontinue use of and segregate the identified Lot Numbers of Catalogue Number 9391-0200 (Plastic cannula – 11 gauge). 2. Complete the supplied Customer Acknowledgement Form to confirm receipt of this notification. 3. Becton Dickinson is requesting that any impacted inventory be returned. 4. Becton Dickinson will arrange for the pick-up of your affected stock and issue a credit to your account.

Device

Plastic Cannula – 11 gauge
  • 모델명 / 제조번호(시리얼번호)
    Plastic Cannula – 11 gauge Catalogue Number: 9391-0200Lot Numbers: 1470303001, 1470304601, 1470306301, 1470311301, 1470314801, 1570314802, 1570317701, 1570317702, 1570317704, 1570322001ARTG Number: 189737
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd