Hickman and Leonard Central Venous Catheter kits 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Bard Access Systems 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
    2016-04-07
  • 사례 출판 날짜
    2016-04-07
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 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: bard hickman and leonard central venous catheter kits medical device manufacturer, bard access systems, inc., has issued a medical device safety alert concerning its hickman and leonard central venous catheter kits. the affected product code numbers are as follows: code numbers: 1) 0600560 ; 2) 0600564; 3) 0600580; 4) 0600600; 5) 0600604; 6) 0600620; 7) 0600630; 8) 0600634; 9) 0600650; 10) 0600654; 11) 0606560; 12) 0606564 the manufacturer became aware that an incorrect expiration period was assigned for the introducer needle of three lots included in various central venous catheter products (hickman and leonard catheters). a 15 year expiration period was assigned to the needle lots when the actual expiration period should have been about 5 years. according to the manufacturer’s health hazard evaluation report, this issue is unlikely to pose an incremental risk of harm. the manufacturer advises affected users to refer to the field safety notice (fsn) for the proper expiration date of the kit due to the needle. this notification does not impact any consumed product or patients with these catheters implanted. the product can be used with the understanding of the correct expiration date mentioned in the fsn. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 april 2016.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Bard Hickman and Leonard Central Venous Catheter kits
  • Manufacturer

Manufacturer