Events

Safety Alert for Needles VACUTAINER BD

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.

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
    I1508-417
  • Event Number
    2013DM-0009943
  • Date
    2015-08-26
  • 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 states that it has identified that the integrated sample body can be separated from the needle, this separation can cause failure in blood extraction and can potentially cause a puncture to the user or the patient, leading to the potential occurrence of adverse events.

Device

Needles VACUTAINER BD
  • Model / Serial
    368835 and 368836 lots: For reference 368835: 4182127, 4206029, 4239482, 4302105, 4302106, 4337456, 4346490, || 4252010, 4259413, 4266252, 4276343, 4323052, 4344023, || 4346070, 5034053, 5041109, 5057410, 5072433, 5072434, || 5086165, 5086166. For reference 368836: 4189358 || , 4198214, 4231358, 4245288, 4268488, 4302103, 4329078, || 4336228, 4346062, 4346068, 5027368, 5072462, 5114342.
  • Product Description
    Needle for collection and collection of blood with security system
  • Manufacturer
    Becton Dickinson and Company

Manufacturer

Becton Dickinson and Company