Events

Protect-A-Line IV extension set 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Vygon 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
    2013-08-20
  • 사례 출판 날짜
    2013-08-20
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130820a.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: vygon protect-a-line iv extension set the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) issued a medical device alert concerning protect-a-line iv extension set (supplied with vented caps) manufactured by vygon. the affected product code is 0832.04 and all batch numbers ending in the letters ba are affected. according to the mhra, there is a risk of air embolus because the affected devices have been supplied with vented caps on the female port (y-site) instead of non-vented caps. identify affected devices. prior to use, remove vented caps from the female port (y-site) of affected devices and replace them with non-vented caps (or a needle free connector) if this port is to remain unused when the set is connected to a patient. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con306143 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 august 2013.

Device

Protect-A-Line IV extension set
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Vygon Protect-A-Line IV extension set
  • Manufacturer
    Vygon

Manufacturer

Vygon