Events

Rappel de Shiley Reusable Cannula Cuffed Tracheostomy Tubes

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Covidien 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-2012-RN-00740-3
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-07-19
  • 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-2012-RN-00740-3
  • 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
    Covidien has received customer reports on certain size 8 shiley reusable cannula, cuffed tracheostomy tubes that have had volume leakage and/or disconnection between the inner and outer cannulae. these events were typically observed during mechanical ventilation and represent a small fraction of the tubes distributed. if a leak and/or disconnection occur, ventilation may be adversely affected and the tracheostomy tube might require immediate replacement.
  • Action
    Covidien is recalling affected stock and is providing phone advice concerning available alternatives.

Device

Shiley Reusable Cannula Cuffed Tracheostomy Tubes
  • Modèle / numéro de série
    Shiley Reusable Cannula Cuffed Tracheostomy Tubes, Product codes: 8FEN, 8LPC, 8LPC-SFenestrated, Cuffed TT, size 8Product code: 8FEN Lot Numbers: 0910000342 - 1101001558; 110201893X - 120600700XLow Pressure Cuffed TT, size 8Product Code: 8LPC Lot Numbers:0910000346 - 1101001823, 110200327X - 120600351XEVAC Low Pressure Cuffed TT, size 8Product Code: 8LPC-S Lot Numbers: 0910001002 - 1103002052, 111000400X - 120600014XARTG Numbers: 181271 & 100137
  • Classification du dispositif
    Anesthesiology Devices
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien 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