Events

NIM Standard Reinforced EMG Endotracheal Tube 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-2016-RN-00929-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00929-1
  • 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 have received reports (reported rate is 0.017%) of emg endotracheal tubes, where the ends of electrode wires at the distal end of the tube have extruded through the wall of the tube, entering the cuff and/or puncturing through the cuff and becoming exposed. four (4) of these complaints involved serious injuries, where an extruded/protruding electrode wire penetrated the tracheal wall or a vocal cord (3 reports overseas); or caused cuff deflation and required re-intubation of the patient (1 report in usa).
  • 조치
    The current Instructions for Use (IFU) is in the process of being updated to reinforce the warnings/precautions with information relative to this bending issue. Users are advised to: · Do not excessively bend the EMG tube, particularly at an acute angle (less than 90°). Excessive bending may cause the wire electrodes to protrude through the tube puncturing through the cuff and becoming exposed. This may result in serious injuries where the exposed wire can penetrate the tracheal wall or a vocal cord, or cause cuff deflation which will require re-intubation of the patient. The copy of the updated IFU will be mailed to the customers, as soon as it becomes available. This action has been closed-out on 02/03/2017.

Device

NIM Standard Reinforced EMG Endotracheal Tube
  • 모델명 / 제조번호(시리얼번호)
    NIM Standard Reinforced EMG Endotracheal TubeProduct Codes: 8229506, 8229507, 8229508 ARTG Number: 169809
  • 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