GLIDESHEATH SLENDER Introducer Catheter 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Terumo Corporation 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
  • 사례 ID
    R1706-254
  • 사례 연번
    2015DM-0013666
  • 날짜
    2017-06-27
  • 사례 국가
  • 사례 출처
    INVIMA
  • 사례 출처 URL
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • 데이터 추가 비고

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Product description: GLIDESHEATH SLENDER consists of an introducer (a sheath and a dilator), a flexible tip mini guide and a vascular access needle. The surface of the pod of this product is covered with a hydrophilic coating exclusive of TERUMO CORPORATION. When the surface of the sheath is wetted, good lubrication is achieved and the coefficient of deflection is markedly reduced. Description of the components: consult the product label for an appropriate description of the components it contains. All the components that enter the blood vessels are radiopaque. Sheath: incorporates a unidirectional valve and a three-way key connected to a lateral tube. The sheath can be used with catheters of the same diameter in FR, and even with catheters up to 2 FR. Minors without any loss of blood through the unidirectional valve. Dilator: the precise adjustment between the sheath and the dilator allows the simultaneous manipulation of both. Mini-guide: supeelástica guide, this surrounded by a smooth surface hemorepelente avoids the possibility of kinks. Vascular access needle: internal metallic needle and a plastic cannula. Inserter of the guide. Instructions of use: the GLIDESHEAT SLENDER is used to facilitate the placement of a catheter in the radial artery through the skin.
  • Manufacturer

Manufacturer