Events

Safety Alert for Umbilical Catheter VYGON

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

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
    R1708-388
  • Event Number
    2014DM-0012392
  • Date
    2017-08-31
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=74
  • 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 has detected that the centimetric mark is not correct, the first mark of the distal tip is 5.5 cm instead of 4 cm, which could lead to potential adverse events on the patient or delays in the procedure.

Device

Umbilical Catheter VYGON
  • Model / Serial
    270.03, lots 050117FR, 230217FR, 241116FR, 280217FR
  • Product Description
    Short-term venous or arterial umbilical catheterization, used for the infusion of solutions, transfusion, exanguineo-transfusion, medication infusion, measurement of blood pressure, blood draws. Directions: store protected from heat, moisture and light. Contraindications: do not use in case of peritonitis, necrotizing enterocolitis, omphalitis, omphalocele, blood circulation in danger of the lower limbs or in the buttocks, or hypertension of the portal vein.
  • Manufacturer
    Vygon S.A.

Manufacturer

Vygon S.A.