Events

Safety Alert for Filter System for Vena Cava BARD

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Cr Bard 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
    R1602-79
  • Event Number
    2014DM-0011295
  • Date
    2016-02-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=155
  • 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 stopcock may present cracks, leading to potential adverse events on patients or patients at the time of the procedure.

Device

Filter System for Vena Cava BARD
  • Model / Serial
    DL900F, lots GFZJ0277 and GFZJ0425.
  • Product Description
    The DENALI filter is indicated for the prevention of recurrent pulmonary emboli after being implanted permanently in the vena cava, in the following situations: • pulmonary thromboembolism when anticoagulants are contraindicated. • Failure of anticoagulant treatment for thromboembolism. • Emergency treatment after pulmonary embolism in which no major benefits are expected with conventional treatment. • Chronic and recurrent pulmonary embolism in which the anticoagulant treatment has failed or is contraindicated.
  • Manufacturer
    Cr Bard Inc || Bard Peripheral Vascular, Inc.

Manufacturer

Cr Bard Inc || Bard Peripheral Vascular, Inc.