Events

Safety Alert for Sterile Intravenous Catheter MP PROMEDICAL

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Disposafe Health and Life Care Ltd.

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
    R1705-155
  • Event Number
    2016DM-0014468
  • Date
    2017-05-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=91
  • 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 informs about the possibility of a weakness in the catheter after the puncture of the patient, which can cause a rupture in the union of the tube and the body of the catheter, leading to potentially adverse events on the patients.

Device

Sterile Intravenous Catheter MP PROMEDICAL
  • Model / Serial
  • Product Description
    Intravenous infusion of solutions, medications, nutrition, contrast media and diagnostic tests, among others. To maintain hydration and / or correct dehydration if the patient is unable to take enough fluid orally. Indicated according to caliber, in adults, children and the elderly.
  • Manufacturer
    Disposafe Health and Life Care Ltd

Manufacturer

Disposafe Health and Life Care Ltd