Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip and Flexislip Stylet, Sterile Pack 의 안전성 경고

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

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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
    2015-09-02
  • 사례 출판 날짜
    2015-09-02
  • 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: teleflex flexi-slip endotracheal tube stylet with soft distal tip and flexislip stylet, sterile pack the medicines & healthcare products regulatory agency (mhra) has issued a medical device safety alert concerning flexi-slip endotracheal tube stylet with soft distal tip (product code: 502501) and flexislip stylet sterile pack (product codes: 503700-000060, 503700-06) manufactured by teleflex medical. the manufacturer has received reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. this may result in a piece of plastic totally or partially occluding the patient’s airway and impairing ventilation, or necessitating invasive removal procedures in order to prevent complications such as atelectasis or pneumonia. according to the manufacturer, no patient injuries have been reported related to this issue. users are advised to quarantine and cease use of the affected products. for details, please refer to the tga website:https://mhra.Filecamp.Com/public/file/29qi-f3qkkkq2 if you are in possession of the affected products, please contact your supplier for necessary actions posted on 2 september 2015.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Teleflex Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip and Flexislip Stylet, Sterile Pack
  • Manufacturer

Manufacturer