Events

Safety Alert for Thoracic catheter - ATRIUM

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Atrium Medical Corporation.

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
    I1611-545
  • Event Number
    2011DM-0007410
  • Date
    2016-11-29
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=111
  • 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 devices are packaged with a label that shows more perforations or holes than the actual number of holes in the device, causing insufficient drainage or the need to repeat the procedure with another catheter, which could lead to present potentially adverse events on patients.

Device

Thoracic catheter - ATRIUM
  • Model / Serial
    Trocar Catheter PVC 8424, 8408, 8410, 8412, 8416, 8420, 8428 and 8432
  • Product Description
    They facilitate the evacuation of air and / or liquid from the thoracic cavity or the mediastinum. Straight configuration, right angle and stroke.
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NIDFSINVIMA