Events

Alerta De Seguridad para Shiley Reusable Cannula Cuffed Tracheostomy Tubes

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
    2012-07-18
  • Fecha de publicación del evento
    2012-07-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120718.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 reusable cannula cuffed tracheostomy tubes medical device manufacturer, covidien, has issued a field safety notice concerning the recall of certain size 8 shiley reusable cannula cuffed tracheostomy tubes. the manufacturer 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 one of the recalled tubes is already in use in a patient, the manufacturer recommends that the tube should be replaced as soon as clinically appropriate as determined by the patient's physician. if the physician advises leaving the tracheostomy tube in place, the manufacturer strongly encourages that the frequency of direct patient observation be increased. unused products from the affected product codes and lots (as stated in the attachment) should be returned to the local supplier. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 july 2012.

Device

Shiley Reusable Cannula Cuffed Tracheostomy Tubes
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Descripción del producto
    Medical Device Safety Alert: Covidien Shiley Reusable Cannula Cuffed Tracheostomy Tubes
  • 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