Events

Alerte De Sécurité sur GLIDESHEATH SLENDER Introducer Catheter

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Terumo Corporation.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    R1706-254
  • Numéro de l'événement
    2015DM-0013666
  • Date
    2017-06-27
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=81
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données

Device

GLIDESHEATH SLENDER Introducer Catheter
  • Modèle / numéro de série
  • Description du dispositif
    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
    Terumo Corporation

Manufacturer

Terumo Corporation