Events

Safety Alert for Intravascular access system - EZ-IO

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

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
    R1609-402
  • Event Number
    2016DM-0014316
  • Date
    2016-09-26
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=120
  • 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 the possibility of contamination of the intraosseous needle during its use due to the lack of instructions for cleaning and disinfection, leading to potentially serious adverse events in patients.

Device

Intravascular access system - EZ-IO
  • Model / Serial
    Driver manual reference 9025, lots 4992333, 5390069 and 5385261.
  • Product Description
    It is indicated for vascular access. It can be used in extractions for commonly ordered laboratories, it accommodates virtually any fluid or medication with safe infusion through peripheral iv, is for pediatric use and in adults, and is used in urgent cases and not urgent.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical