Events

Alerta De Seguridad O Notificaciones De Seguridad para BD Neoflon™ IV cannula

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 Becton Dickinson.

¿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/2013/074
  • Número del evento
    CON322755
  • Fecha
    2013-10-10
  • Fecha de publicación del evento
    2013-10-10
  • 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/CON322755?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
    Risk of delay in treatment due to increased risk of the catheter buckling during initial puncture of skin. due to a change in manufacturing process, the manufacturer has become aware of an increase in reported incidents of the catheter buckling in use. becton dickinson does not currently have stock available to replace affected devices. new product is being manufactured and should be available for supply from the beginning of october. becton dickinson has not issued a field safety notice in relation to this issue.
  • Acción
    Ensure staff are aware of this potential problem. Exercise additional care and vigilance when using this product and, if possible, use alternative devices until new product is available from Becton Dickinson. Report any incidents of devices buckling to the MHRA.

Device

BD Neoflon™ IV cannula
  • Modelo / Serial
  • Descripción del producto
    BD Neoflon™ IV cannula All lots of: Product code: 391350, size: 24 G, NHSSC code: FSP070 Product code: 391349, size: 26 G. This is a disposable device designed to gain access to peripheral veins of the patient’s blood system for rehydration, parenteral nutrition, medication delivery, blood transfusion and monitoring purposes.  This device is intended for use on neonatal, paediatric and geriatric patients.
  • Manufacturer
    Becton Dickinson

Manufacturer

Becton Dickinson