Events

Safety Alert for PARADIGM QUICK SET MEDTRONIC INFUSION CATHETER - ANVISA Record: 10339190272. Model: MMT-397 - Lot 8200442.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Medtronic Comercial Ltda..

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
    969
  • Date
    2009-07-20
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    See attachments.
  • Reason
    Paradigm quick set infusion catheter unexpected behavior at the time of the prime manual associated with the saturation of the p-cap opening membrane with silicone oil and therefore not allowing air to escape from the reservoir compartment can prevent ventilation of the pump of insulin, potentially resulting in excess or lack of insulin to be delivered, leading to serious injury or death.
  • Action
    The actions recommended to the users of the product are as follows: (1) Immediate interruption of the use of infusion kits of this lot; (2) Switch to an infusion kit that has not been affected or implement the injection contingency plan established with your physician; (3) Contact your supplier to arrange for the return and replacement of any Quick Set "Batch 8" infusion kits at no additional charge.

Device

PARADIGM QUICK SET MEDTRONIC INFUSION CATHETER - ANVISA Record: 10339190272. Model: MMT-397 - Lot...

Manufacturer

Medtronic Comercial Ltda.
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA