Events

Safety Alert for Breast Tracing Guides GHIATAS

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by 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
    R1704-149
  • Event Number
    2009DM-0004966
  • Date
    2017-04-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=92
  • 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 identified combinations of specific product code / lot number that may be at risk of containing a breast location wire not compatible with an mri instead of a compatible one, leading to potentially delays in processing and adverse events on the patients.

Device

Breast Tracing Guides GHIATAS
  • Model / Serial
  • Product Description
    This device is designed to be used during breast injury surgical procedures as a guide for the surgeon to follow during the excision of the injury.
  • Manufacturer
    Bard Peripheral Vascular, Inc.

Manufacturer

Bard Peripheral Vascular, Inc.