Events

Alerta De Seguridad para BARD TRUGUIDE disposable coaxial biopsy needle

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 Precision Needle Manufacturing, Inc. || Bard Peripheral Vascular, Inc..

¿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
    I1608-330
  • Número del evento
    2013DM-0010824
  • Fecha
    2016-08-04
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=127
  • 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
  • Causa
    The manufacturer reports that it has detected that the referenced medical device may contain two stilettos with a coaxial trocar tip or two blunt-tipped stylets, instead of one of each, leading to potentially adverse events on the patients oprugating the surgical time.

Device

BARD TRUGUIDE disposable coaxial biopsy needle
  • Modelo / Serial
    C1816B, lot REZK0479.
  • Descripción del producto
    The BARD TRUGUIDE disposable coaxial biopsy needle is a three-part device consisting of an external cannula with a coupled LUER LOCK female cone, an internal stylus with a coupled LUER LOCK male cone, and a flexible slide-style depth stop. The BARD TRUGUIDE disposable coaxial biopsy needle is designed for use with BARD biopsy disposable instruments and disposable biopsy needles BARDs guidelines for using the coaxial biopsy needle guide seusa as a guide for soft tissue biopsy samples such as the liver, kidney, prostate, spleen, lymph nodes and various soft tumors.
  • Manufacturer
    Precision Needle Manufacturing, Inc. || Bard Peripheral Vascular, Inc.

Manufacturer

Precision Needle Manufacturing, Inc. || Bard Peripheral Vascular, Inc.
  • Source
    NIDFSINVIMA