Events

Medtronic Clip Gun Magazine, Raney Clip Gun 5pk 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic Australasia 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-2018-RN-00488-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-05-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00488-1
  • 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
    Medtronic has identified certain clip gun magazines have failed to meet the requirement of post-sterile seal integrity. testing performed by medtronic showed that the packaging sterile barrier of the pmc manufactured magazine cm8902, does not comply with the applicable packaging standard for terminally sterilised medical devices.Whilst the instructions for use (ifu) state “do not use if package has been previously opened or damaged”, it is possible that the seal breach may go undetected by the users’ naked eye. to date, medtronic has not received any complaints related to a sterile breach or infection that could potentially be related to a sterile breach.
  • 조치
    Medtronic is advising customers to identify affected product and return any unused units to Medtronic. Instructions for return can be found in the Customer Confirmation Form provided with the Customer Letter. Clinicians and their Patients who may have received the listed devices should monitor the patient’s condition to determine if there are any signs of infection. If this is the case, the patient should seek medical attention immediately to treat the infection.

Device

Medtronic Clip Gun Magazine, Raney Clip Gun 5pk
  • 모델명 / 제조번호(시리얼번호)
    Medtronic Clip Gun Magazine, Raney Clip Gun 5pkModel Number: CM8902Batch Numbers: 54984 and 57188ARTG Number: 98837(Medtronic Australasia - Clip, scalp, single use)
  • 의료기기 분류등급
    Neurological Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia 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