Events

Rappel de ENDOTRACHEAL TUBE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MEDTRONIC OF CANADA LTD..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    20165
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-06-28
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Medtronic has received complaint reports of "wire through lumen" "cuff leakage" or some variation where a wire was found out of place or to have penetrated the channel wall. most of these reports do not indicate patient injury or adverse health consequences. therefore and to ensure patient safety and out of an abundance of caution medtronic is providing a technical bulletin to reinforce and remind customers of the proper handling of the tube during intubation appropriate warnings and precautions that could relate to the complaints and that are included in the instructions for use (ifu).

Device

ENDOTRACHEAL TUBE
  • Modèle / numéro de série
    Model Catalog: 8229308 (Lot serial: All Lots); Model Catalog: 8229306 (Lot serial: All Lots); Model Catalog: 8229506 (Lot serial: All Lots); Model Catalog: 8229507 (Lot serial: All Lots); Model Catalog: 8229508 (Lot serial: All Lots); Model Catalog: 8229307 (Lot serial: All Lots)
  • Description du dispositif
    ENDOTRACHEAL TUBE
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Adresse du fabricant
    BRAMPTON
  • 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
    HC