Events

Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff 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-00412-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-05-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00412-1
  • 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 is conducting this recall following reports from customers where patients who recently switched from the current shiley neonatal and pediatric products to these affected products as listed above, experienced discomfort immediately after the switch in a limited number of situations. in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels, were also observed immediately after the switch. in all reported cases, patients were administered immediate medical attention. serious injuries, events that required medical intervention, have occurred or could occur due to the failure mode associated with this recall. there have been 12 reports of serious injuries. no deaths have been reported.
  • 조치
    Covidien is requesting hospitals to discontinue use and quarantine all affected devices. Covidien will organise for the recovery of the affected devices. If one of the recalled Shiley tracheostomy tubes is currently in use in a patient, and the patient is not experiencing any discomfort, breathing difficulties or any other issues related to the tube, Covidien recommends that the patient’s physician evaluate the continued use.

Device

Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff
  • 모델명 / 제조번호(시리얼번호)
    Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard CuffNeonatal -Tracheostomy Tube Cuffless 2.5NEF, 3.0NEF, 3.5NEF, 4.0NEF & 4.5NEF-Tracheostomy Tube with TaperGuard Cuff2.5NCF, 3.0NCF, 3.5NCFPediatric -Tracheostomy Tube Cuffless 2.5PEF, 3.0PEF, 3.5PEF, 4.0PEF, 4.5PEF, 5.0PEF, 5.5PEF-Tracheostomy Tube Long Cuffless5.0PELF, 5.5PELF, 6.0PELF, 6.5PELFAll lot numbers beginning with 12, 13 and 14 & 15A0152JZX & 15A0154JZX
  • 의료기기 분류등급
    Anesthesiology Devices
  • 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