Events

Alerta De Seguridad para Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Covidien.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2015-05-15
  • Fecha de publicación del evento
    2015-05-15
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150515.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Descripción del producto
    Medical Device Safety Alert: Covidien Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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