Events

Safety Alert for Medcomp catheters

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Martech Medical Products, S.A. De C.V. || Medical Components, Inc. (Medcomp).

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
    R1607-311
  • Event Number
    2016DM-0001609-R2
  • Date
    2016-07-29
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=129
  • 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 detected during the washing of the device before the insertion or post-insertion of the purple tubes, leading to possible adverse events on the patients.

Device

Medcomp catheters
  • Model / Serial
    MR17034101, MR17034102, MR17034105, MRCTP41010, MRCTP41024, MRCTP41028, MRCTP41029, MR17035101, || MR17035101-KR, MR17035102, MR17035102-KR, || MRCTP51028, MR17035105, MR17036201, MR17036201- || KR, MR17036202, MRCTP62028, MR28035101, || MR28036201 and MR28036221, specific lots.
  • Product Description
    For short and long term vascular and peritoneal access.
  • Manufacturer
    Martech Medical Products, S.A. De C.V. || Medical Components, Inc. (Medcomp)

Manufacturer

Martech Medical Products, S.A. De C.V. || Medical Components, Inc. (Medcomp)
  • Source
    NIDFSINVIMA