Events

Safety Alert for Connector and Needle Free System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by ICU Medical 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
    R1609-403
  • Event Number
    2011DM-0007580
  • Date
    2016-09-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=122
  • 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 he has received reports of leaks in referenced devices, the risk of leakage could exist when connected to the dialysis tube during hemodialysis treatment, and can lead to blood loss, leading to potentially adverse events occurring in patients.

Device

Connector and Needle Free System
  • Model / Serial
    D-1000, lot 3244560
  • Product Description
    Injection system used in hemodialysis and for the preparation and administration in oncology, since being a closed microbiological and mechanical system guarantees an internal flow in which the liquids that pass through the connector never come into contact with any component exposed to the environment; ideal for the use of medicines used in chemotherapy.
  • Manufacturer
    ICU Medical Inc.

Manufacturer

ICU Medical Inc.