Safety Alert for Lumen Double Catheter

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Origen Biomedical 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
    R1709-458
  • Event Number
    2015DM-0013177
  • Date
    2017-09-29
  • Event Country
  • Event Source
    INVIMA
  • Event Source URL
  • 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 been able to identify the presentation of adverse events caused by the performance of the device, leading to the presence of possible serious adverse events on the patients.

Device

  • Model / Serial
    VV28F, lots N18487, N18487-1
  • Product Classification
  • Product Description
    They are designed to repair or replace the peripheral arteries. ORIGIN is double lumen vascular access catheters are indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood into the internal jugular vein during vitalextracorporeal support procedures (ECLS or ECMO).
  • Manufacturer

Manufacturer