Events

Safety Alert for needles for bone and bone marrow

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

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
    R1508-372
  • Event Number
    2010DM-0006654
  • Date
    2015-08-05
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=173
  • 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 detected potential failures of the packaging of the primary packaging of the device, compromising the sterility of the product, leading to possible adverse events on the patients.

Device

needles for bone and bone marrow
  • Model / Serial
    DBMNI1501, DBMNJ1104TL, DBMNI1601 and DBMNJ0804TL
  • Product Description
    The bone needles are specifically designed for the collection and / or aspiration of osseous bone tissue samples. Access to the bone / bone marrow sample is done mechanically by the cortical surfaces of the device.
  • Manufacturer
    Argon Medical Devices

Manufacturer

Argon Medical Devices