Events

Alerta De Seguridad para Portex Bivona Inner Cannula for Bivona Adult Tracheostomy Tubes

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

¿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
    2015-04-20
  • Fecha de publicación del evento
    2015-04-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150420.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: smiths medical portex bivona inner cannula for bivona adult tracheostomy tubes medical device manufacturer, smiths medical, has issued a medical device safety alert concerning its portex bivona inner cannula for bivona adult tracheostomy tubes [model/catalogue numbers: brc270, brc275, brc280, brc285, brc290, brca70, brca75, brca80, brca85, brca90; all lot numbers]. the manufacturer has become aware of the potential for compression of the inner cannula to occur as a result of handling or certain cleaning methods used with inner cannulae. compression can result in a shorter overall length. use of an inner cannula which is too short may lead to a build-up of secretions within the end of the tracheostomy tube which may cause infection or occlusion. the inner cannula should be handled and cleaned with care, and according to the instructions for use (“ifu”). according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 april 2015.

Device

Portex Bivona Inner Cannula for Bivona Adult Tracheostomy Tubes
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Smiths Medical Portex Bivona Inner Cannula for Bivona Adult Tracheostomy Tubes
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical