Events

Safety Alert for MEDRAD-BAYER Contrast Media Injector System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Bayer Medical Care 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
    R1702-37
  • Event Number
    2016EBC-0015488
  • Date
    2017-02-14
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=103
  • 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 states that the referenced devices may fail in occlusion situations, when it is more than one (1) year from the date of manufacture, therefore, there may be a saline leak as a radiopharmaceutical within the ionization chamber, resulting in in the application of an incomplete dose, which could result in the need to repeat the test or could also lead to possible exposure to radiation from the operator if the chamber is open, leading to delays in the procedure or possible adverse events on the patient and user.

Device

MEDRAD-BAYER Contrast Media Injector System
  • Model / Serial
  • Product Description
    The MEDRAD INTEGO PET INFUSION SYSTEM is an infusion system for PET INTEGO is designed to administer accurate doses of radiopharmaceutical (RP) labeled with 18f-fluorodeoxyglucose (18f-fdg) or 18f-sodium fluoride (18f-naf) and physiological solutions of Usual use during diagnostic procedures using molecular imaging (median-nuclear) techniques. The INTEGO PET infusion system is also designed to effectively protect medical personnel from radiation exposure to fluoride-18 (18f) during nuclear medicine diagnostic procedures.
  • Manufacturer
    Bayer Medical Care Inc

Manufacturer

Bayer Medical Care Inc
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    NIDFSINVIMA