Events

Alerte De Sécurité sur Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Covidien.

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
  • Date
    2015-05-15
  • Date de publication de l'événement
    2015-05-15
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150515.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: covidien shiley neonatal, paediatric and long paediatric tracheostomy tube, cuffless and with taperguard cuff australian therapeutic goods administration (tga) posted a medical device safety alert concerning shiley neonatal, paediatric and long paediatric tracheostomy tube, cuffless and with taperguard cuff, manufactured by covidien. the affected devices are identified as follows:- the affected devices are identified as follow:- neonatal tracheostomy tube cuffless: 2.5nef, 3.0nef, 3.5nef, 4.0nef & 4.5nef tracheostomy tube with taperguard cuff: 2.5ncf, 3.0ncf, 3.5ncf pediatric tracheostomy tube cuffless : 2.5pef, 3.0pef, 3.5pef, 4.0pef, 4.5pef, 5.0pef, 5.5pef tracheostomy tube long cuffless: 5.0pelf, 5.5pelf, 6.0pelf, 6.5pelf all lot numbers beginning with 12, 13 and 14 & 15a0152jzx & 15a0154jzx the manufacturer is conducting this recall following reports from customers where patients who recently switched from the current shiley neonatal and pediatric products to the affected products experienced discomfort immediately after the switch in a limited number of situations. in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels, were observed immediately after the switch. serious injuries, events that required medical intervention, have occurred or could occur due to the failure mode associated with this recall. the manufacturer is requesting hospitals to discontinue use and quarantine all affected devices. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00412-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 may 2015.

Device

Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff
  • Modèle / numéro de série
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    Medical Device Safety Alert: Covidien Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • 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
    DH