Events

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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par DAUTO SUTURE DO BRASIL LTDA.; COVIDIEN LLC.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1572
  • Date
    2015-05-11
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    According to the company: "PATIENTS WHO HAVE CURRENTLY HAVE THE IMPLANTED DEVICE DOES NOT PRESENT ADDITIONAL RISK THROUGH THIS CONDITION."
  • Cause
    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
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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