Events

Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Covidien 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2015-05-15
  • 사례 출판 날짜
    2015-05-15
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150515.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: covidien shiley neonatal, paediatric and long paediatric tracheostomy tube, cuffless and with taperguard cuff australian therapeutic goods administration (tga) posted a medical device safety alert concerning shiley neonatal, paediatric and long paediatric tracheostomy tube, cuffless and with taperguard cuff, manufactured by covidien. the affected devices are identified as follows:- the affected devices are identified as follow:- neonatal tracheostomy tube cuffless: 2.5nef, 3.0nef, 3.5nef, 4.0nef & 4.5nef tracheostomy tube with taperguard cuff: 2.5ncf, 3.0ncf, 3.5ncf pediatric tracheostomy tube cuffless : 2.5pef, 3.0pef, 3.5pef, 4.0pef, 4.5pef, 5.0pef, 5.5pef tracheostomy tube long cuffless: 5.0pelf, 5.5pelf, 6.0pelf, 6.5pelf all lot numbers beginning with 12, 13 and 14 & 15a0152jzx & 15a0154jzx the manufacturer is conducting this recall following reports from customers where patients who recently switched from the current shiley neonatal and pediatric products to the affected products 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 observed immediately after the switch. serious injuries, events that required medical intervention, have occurred or could occur due to the failure mode associated with this recall. the manufacturer is requesting hospitals to discontinue use and quarantine all affected devices. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00412-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 may 2015.

Device

Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Anesthesiology Devices
  • 제품 설명
    Medical Device Safety Alert: Covidien Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • 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
    DH