Events

Check-Flo Blue Valve Devices 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Cook Medical 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
    2017-02-09
  • 사례 출판 날짜
    2017-02-09
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170209.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: cook medical check-flo blue valve devices medical device manufacturer, cook medical, has issued a medical device safety alert concerning its check-flo blue valve devices, details product brand name (catalogue identifier[prefix/suffix]) as below: check-flo hemostasis assembly ( cfm-200) flexor radial access set ( kcfn-4.0(5.0, 6.0, 7.0)- / -ra-(s)-hc) triforce peripheral crossing set ( kcxs-5.0- / -rb-0/0-hc, kcxs-5.0- / -rb-0/dav-hc, kcxs-5.0- / -rb-mpb/0-hc, kcxs-5.0- / -rb-mpb/dav-hc) check-flo performer introducer set ( rcf-4.0(5.0, 6.0, 7.0, 8.0)- / -bv check-flo performer introducer ( rcfw-4.0(5.0, 6.0, 7.0, 8.0)- / -bv micropuncture check-flo performer introducer set ( rcfn-4.0(5.0, 6.0, 7.0)- / -mpis-nt-bv check-flo introducer hausdorf-lock atrial ( rcfw-7.0(8.0)-38-75-rb-hla-091100-bv the manufacturer identified an increase in reports of blood loss associated with devices using a specific hemostatic valve design (referred to as the “blue” valve or polyisoprene valve). in november 2015, products manufactured with the hemostatic blue valve design were either obsoleted or changed to incorporate a different valve design with improved hemostasis. the manufacturer has continued to receive reports of blood loss associated with the earlier generation products containing the “blue” valve and therefore has initiated this action on those devices. according to the manufacturer, potential adverse events that may occur if these devices were used in the arterial system (flexor radial access sets) include delay in procedure and blood loss. if devices were used in the central venous system, adverse events that may occur include delay in procedure, blood loss, or air embolism. the manufacturer advises users to examine inventory immediately to determine if they have affected products and quarantine affected products. return the affected products to the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 9 february 2017.

Device

Check-Flo Blue Valve Devices
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Cook Medical Check-Flo Blue Valve Devices
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical