Events

Safety Alert for Pleural Drainage System- PLEUR-EVAC

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

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
    I1604-159
  • Event Number
    2011DM-0006876
  • Date
    2016-04-15
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=146
  • 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 identified that the devices do not have the appropriate external labeling for identification, the only possible way would be to break the sterile barrier to access the label of the individual unit, which could lead to potentially occuring adverse events on patients or delays in the procedures .

Device

Pleural Drainage System- PLEUR-EVAC
  • Model / Serial
    A-1500-08LF, A-4301-08LF, A-6000-08LF, A-6002-08LF, A-6020-08LF, A-7000-08LF, A-8000-08LF, A-8002-08LF, || S0500, S-100-08LF, S-1100-08LF and S-1102-08LF, specific lots.
  • Product Description
    To continuously drain and release the pleural cavity from the anomalous presence of air or excessive fluid, thus restoring the negative pressure necessary for a proper pulmonary expansion, or allowing the drainage of the mediastinal cavity that allows correct operation.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical