Retiro De Equipo (Recall) de Becton Dickinson Plastipak 50ml Luer Lok Syringe

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 & Company Ltd.

¿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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Bd has received complaints concerning an increase in the occurrence of occlusion alarms with the bd plastipak™ 50ml luer lok syringes. the root cause has been determined to be increased plunger rod forces primarily due to the interaction between the syringe barrel and the rubber stopper. initially bd recommended a change in the settings of the syringe pumps. however, investigation after continued complaints were received has revealed that it was not technically feasible to change the pump settings on some types of syringe pumps. bd has redesigned the syringe plunger to reduce the plunger forces required.
  • Acción
    Manufacturer to issue advice regarding use