Events

Rappel de NIM Standard Reinforced EMG Endotracheal Tube

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtronic Australasia Pty 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
    RC-2016-RN-00929-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-25
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00929-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Medtronic have received reports (reported rate is 0.017%) of emg endotracheal tubes, where the ends of electrode wires at the distal end of the tube have extruded through the wall of the tube, entering the cuff and/or puncturing through the cuff and becoming exposed. four (4) of these complaints involved serious injuries, where an extruded/protruding electrode wire penetrated the tracheal wall or a vocal cord (3 reports overseas); or caused cuff deflation and required re-intubation of the patient (1 report in usa).
  • Action
    The current Instructions for Use (IFU) is in the process of being updated to reinforce the warnings/precautions with information relative to this bending issue. Users are advised to: · Do not excessively bend the EMG tube, particularly at an acute angle (less than 90°). Excessive bending may cause the wire electrodes to protrude through the tube puncturing through the cuff and becoming exposed. This may result in serious injuries where the exposed wire can penetrate the tracheal wall or a vocal cord, or cause cuff deflation which will require re-intubation of the patient. The copy of the updated IFU will be mailed to the customers, as soon as it becomes available. This action has been closed-out on 02/03/2017.

Device

NIM Standard Reinforced EMG Endotracheal Tube
  • Modèle / numéro de série
    NIM Standard Reinforced EMG Endotracheal TubeProduct Codes: 8229506, 8229507, 8229508 ARTG Number: 169809
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA