Events

Safety Alert for Hypodermic Needles - K-PACK II Needles

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

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
    A1504-147
  • Event Number
    2008DM-0002778
  • Date
    2015-04-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=181
  • 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 who reports a potential failure in the quality of the referenced medical devices, the suspicion lies in the connection between the stainless steel tube and the needle hub, probably due to adequate hardening of the adhesive, which may leave some residue on the needle, which can lead to the potential occurrence of serious adverse events on the patient.

Device

Hypodermic Needles - K-PACK II Needles
  • Model / Serial
    K-PACK II
  • Product Description
    The K-PACK II needles are indicated for aspirating or injecting fluids from or to the human body in combination with hypodermic syringes.
  • Manufacturer
    Terumo Europe N.V

Manufacturer

Terumo Europe N.V