Events

Safety Alert for Central Catheters for Peripheral Insertion

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Arrow Internacional De Chihuahua S.A. De C.V. || Arrow International Inc. || Arrow..

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
    I1702-35
  • Event Number
    2011DM-0000097-R1
  • Date
    2017-02-10
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=103
  • 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 indicates that it has received reports where the components of the detachment sheath on the referenced devices may explode, it has also detected that the included instructions for use (ifu) do not inform the user that an incision on the skin or an alternative extension method may be necessary in cases of difficult insertions, leading to possible serious adverse events on the patient and delays in the surgical procedure.

Device

Central Catheters for Peripheral Insertion

Manufacturer

Arrow Internacional De Chihuahua S.A. De C.V. || Arrow International Inc. || Arrow.