Events

Trellis 6 and Trellis 8 Peripheral Infusion System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Covidien 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-00267-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00267-1
  • 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
    Covidien (now medtronic) is conducting a recall of the trellis 6 and trellis 8 peripheral infusion systems due to potential for a sterility breach of the outer packaging or pouch material of all lots manufactured. a breach of the outer pouch may compromise the outside surface sterility of the inner pouch and does not directly affect the sterility of the device components within the inner pouch. this potential for a sterile breach in the outer pouch material was discovered during standard internal packaging tests. the breach in the pouch barrier is likely not detectable by visual inspection of the product. covidien has identified possible causes for the pouch damage and has taken actions to prevent distribution of product that may be affected by this issue.Covidien has received no complaints and is not aware of any patient injury or death related to the issue.
  • 조치
    Covidien is Recalling all affected units from the market and will issue a credit for unused and unexpired devices. This action has been closed-out on 09/08/2016.

Device

Trellis 6 and Trellis 8 Peripheral Infusion System
  • 모델명 / 제조번호(시리얼번호)
    Trellis 6 and Trellis 8 Peripheral Infusion SystemARTG Number: 229708
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA