Events

Retiro De Equipo (Recall) de SmartSite Add-on Bag Access Device

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Becton Dickinson and Company.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    20959
  • Fecha de inicio del evento
    2016-12-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Becton Dickinson Ltd, 14B George Bourke Drive, Mt Wellington, Auckland 1060
  • Causa
    The manufacturer has received reports of leakages between the spike port and the drip chamber spike and have identified potential risks with the smart site add-on bag access device model number 10013365 for 16 lot numbers. the separation and leakage may occur during infusion.
  • Acción
    Product to be returned to supplier

Device

SmartSite Add-on Bag Access Device

Manufacturer

Becton Dickinson and Company