Events

Alerta De Seguridad para GLIDESHEATH SLENDER Introducer Catheter

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Terumo Corporation.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    R1706-254
  • Número del evento
    2015DM-0013666
  • Fecha
    2017-06-27
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=81
  • Notas / Alertas
    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.
  • Notas adicionales en la data

Device

GLIDESHEATH SLENDER Introducer Catheter
  • Modelo / Serial
  • Descripción del producto
    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
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    NIDFSINVIMA