Events

Alerte De Sécurité sur Commercial Name: Cannula Kit for Recurrent Stimulation with Stimulating Probe //// Anvisa Record: 10339190172 /// Risk Class: II. Affected model (s): 8229306, 8229307, 8229308 and Lot (s) / Serial number (s) affected: attached document.

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 MEDTRONIC COMERCIAL LTDA.; MEDTRONIC XOMED INC.

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
    1932
  • Date
    2016-07-01
  • 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
    Recommendations to Users and Patients: 1) Thoroughly inspect the cannula, including the cuff, wires and distal tip to ensure that all cannula components are secure and in place; and inflate the cuff with 15-20 cc of air to check for leaks; [Be sure to remove all air before intubation]. 2) Use standard fixed (non-malleable) probes matching the maximum to the natural curve of the tube; or, if a malleable probe is used, be careful to form a gradual curve in the probe that corresponds to the maximum to the natural curve of the tube and / or to allow the probe to slide easily into and out of the cannula. 3) DO NOT bend or flex excessively the cannula or electrodes prior to or during the intubation process. 4) Lubricate the cuff with a non-paralyzing aqueous lubricant for intubation; and use a lubricated probe. #### UPDATED ON 7/24/2017, the company submitted the completion report of the field action proving the sending of the security warning to the client.
  • Cause
    In the past two years, the manufacturer has received reports of the endotracheal cannulae in which the ends of the electrode wires at the distal end of the cannula have extruded through the cannula wall, entering the cuff and / or piercing the cuff and becoming exposed. four (4) of these complaints involved serious injuries in which an extruded / protruding electrode wire penetrated the tracheal wall or vocal cord (3 reports in china); or caused cuff disinflation and required patient reintubation (1 us report).
  • Action
    Guidance to Health Professionals (Recommendations to users and patients) /// Changing Instructions for Use. Action code FA713.

Device

Commercial Name: Cannula Kit for Recurrent Stimulation with Stimulating Probe //// Anvisa Record:...

Manufacturer

MEDTRONIC COMERCIAL LTDA.; MEDTRONIC XOMED INC
  • 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