Retiro De Equipo (Recall) de BD Q-Syte Luer Access Split Septum Device(Connector designed to allow access to injection sites for delivery of medication)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Becton Dickinson Pty 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
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Some units have an off-centred slit in the silicon septum resulting in a thinner column wall. when actuated, units with a thinner column wall may tear leading to leakage of infusate/medication or blood from the side vent opening. in addition to leakage, the manufacturer has identified that there is a smallpotential risk for air to enter the bloodstream which could result in air embolism.
  • Acción
    Customers are advised to discontinue use of and immediately quarantine any of the affected stock. This action has been closed-out on 09/08/2016.