Events

BARD Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap 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-01075-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-08-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01075-1
  • 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, bard medical division (bmd) has identified that certain product code / lot number combinations may be at risk for having a slit defect on the package which may affect product sterility. use of a potentially non-sterile bard irrigation syringe could introduce microorganisms which may lead to a varying degree of risk including localised and/or systemic infectious complications. in the event this occurred, the patient may require medical intervention. there have been no reports of patient injuries as a result of this issue.
  • 조치
    Bard is advising users that if affected product has been used, to monitor the patient for symptoms and signs of localised and/or systemic infection. Users are advised to inspect stock and quarantine any remaining units of the affected batches for return to Bard. This action has been closed-out on 03/03/2017.

Device

BARD Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap
  • 모델명 / 제조번호(시리얼번호)
    BARD Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and CapProduct Code: 0038460Lot Numbers: NGZD0924, NGZD4923, NGZD3989, NGZD3241Expiration dates range between April 30, 2020 and July 31, 2020ARTG Number: 137628
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd