Events

Safety Alert for PRODUCT: Double Catheter Lumen for Hemodialysis PALINDROME HSI //// REGISTRATION: 10349000341 //// RISK CLASS 4 (Maximum Risk) //// MODELS :. 8888145048; 8888145049; 8888145050; 8888145057 //// LOTS (See ANNEX)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by DAUTO SUTURE DO BRASIL LTDA.; COVIDIEN LLC.

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
    1572
  • Date
    2015-05-11
  • 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
    According to the company: "PATIENTS WHO HAVE CURRENTLY HAVE THE IMPLANTED DEVICE DOES NOT PRESENT ADDITIONAL RISK THROUGH THIS CONDITION."
  • Reason
    Tests performed by emprea suggest that affected products can not meet the minimum silver release specification for the entire 30 day period. the silver eliminated by the shelter has the purpose of reducing microbial colonization on the catheter surface and subcutaneous tunnel treatment. the results of the tests show that the release of silver initially meets the specification, but, after the nine day, the release of silver continues in reduced level. patients who have current device have no additional risk as to the condition. medtronic has not received adverse effects related to this problem.
  • Action
    Company sent letter to customers (distribution chain) (See APPENDIX) informing about the Pickup and Return of the product - Action Pickup / Return to the manufacturer - Code: PALINDROME

Device

PRODUCT: Double Catheter Lumen for Hemodialysis PALINDROME HSI //// REGISTRATION: 10349000341 ///...

Manufacturer

DAUTO SUTURE DO BRASIL LTDA.; COVIDIEN LLC
  • 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