Events

Alerta De Seguridad O Notificaciones De Seguridad para Bivona® Neonatal, Pediatric and Flextend

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Smiths Medical.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2012/002
  • Número del evento
    CON140753
  • Fecha
    2012-01-19
  • Fecha de publicación del evento
    2012-01-19
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON140753?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Incorrectly connected accessories may be difficult to remove, requiring excessive force to disconnect.  this may cause the tube to dislodge, requiring it to be changed. the manufacturer has initiated a recall of affected tubes. the manufacturer issued a field safety notice (fsn) – dated 15 november 2011 – but has not had confirmation from all users that they have received and acted on this information.
  • Acción
    See appendix one for affected reorder numbers, and NHS supply chain codes where applicable. Locate and quarantine all unused affected devices. Complete and return the Smiths Medical confirmation form, even if you no longer have affected units in stock. Return all unused affected devices as described in the Field Safety Notice issued by Smiths Medical. For patients with affected tubes in situ: Review the advice on correct use provided in the Customer Information Bulletin found in the FSN and the Tracheostomy – Neo-Pedi” guidance video (external link) on the Smiths Medical website.

Device

Bivona® Neonatal, Pediatric and Flextend
  • Modelo / Serial
  • Descripción del producto
    Tracheostomy tubes: Bivona®  Neonatal, Pediatric and Flextend. Lot numbers from 1631477 to 1923406 inclusive. Only devices intended for neonatal and paediatric use are affected. Only tubes with an integrated connector that does not allow for use of a disconnect wedge (TR3) are affected. Examples of accessories that can be used with the affected tubes include: speaking valves, heat moisture exchangers, and breathing circuit connectors. A design modification was implemented in November 2010 to address this problem.
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical