Events

Safety Alert for BARD TRUGUIDE disposable coaxial biopsy needle

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Precision Needle Manufacturing, Inc. || Bard Peripheral Vascular, Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1608-330
  • Event Number
    2013DM-0010824
  • Date
    2016-08-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=127
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    C1816B, lot REZK0479.
  • Product Description
    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