Events

Alerta De Seguridad O Notificaciones De Seguridad para Single-use syringes: Plastipak 50ml Luer Lok

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 BD 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/2014/003
  • Número del evento
    CON364175
  • Fecha
    2014-01-17
  • Fecha de publicación del evento
    2014-01-17
  • 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/CON364175?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 or interruption to treatment when these syringes are used in power-driven syringe pumps.  bd continues to receive reports of occlusion alarms triggering due to an increased plunger movement force, which was introduced by a design change in april 2012.  bd is in the process of modifying the design to lower plunger forces. the new design will not be available before the end of january 2014.
  • Acción
    Be aware of this issue and the likelihood that you may continue to experience unexpected occlusion alarms if using the current syringes in power-driven syringe pumps. Be aware that BD has issued a Field Safety Notice (FSN) informing users of this issue. This replaces their FSN of 11 April 2013. Contact BD for further advice on dealing with this issue. When new stock is available, contact BD to discuss a managed changeover. MDA/2013/024 has been withdrawn. Action by: All healthcare and care workers who use these devices and those involved in their purchase, supply and distribution. All those responsible for the maintenance and service of syringe pumps.

Device

Single-use syringes: Plastipak 50ml Luer Lok
  • Modelo / Serial
  • Descripción del producto
    Single-use syringes: Plastipak TM 50ml Luer Lok Product codes affected: 300223 non sterile, 300865 sterile (NHS Supply Chain code FWC034 England only), 300869 Amber – sterile. All lot numbers are affected. Stock of the new design (with lower plunger forces) can be identified by an ‘N’ preceding the product code for example:  N Ref 300865
  • Manufacturer
    BD Medical

Manufacturer

BD Medical