Events

Safety Alert for Equipment for Blood Removal with Pressure Button VACUTAINER

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Becton Dickinson And Company || Becton Dickinson Infusion Theraphy Systems 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
    R1608-344
  • Event Number
    2014DM-0011280
  • Date
    2016-08-18
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=125
  • 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 detected that the referenced devices do not work as expected after the activation of the safety device that retracts the needle, the effect could potentially expose the needle and cause an accidental puncture or leakage of blood, the cause has been attributed to a failure in the process of manufacture, leading to its use may cause possible adverse events on patients or users.

Device

Equipment for Blood Removal with Pressure Button VACUTAINER

Manufacturer

Becton Dickinson And Company || Becton Dickinson Infusion Theraphy Systems Inc