Events

Retiro De Equipo (Recall) de Cavafix (used for the catheterisation of vena cava)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por B Braun Australia 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
    Recall
  • ID del evento
    RC-2014-RN-00419-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-08
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00419-1
  • 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
    In the course of internal quality checks the manufacturer discovered that aging of these products can result in deposits of particles on the surface of the catheters. to date, no harm or any other adverse patient outcome which could be associated to the above described observation has been reported to b. braun melsungen ag.
  • Acción
    B.Braun is requesting their customers to inspect their stock and quarantine any units from the affected batches. All affected stock will be recovered by B.Braun and a credit note issued. This action has been closed-out on 29/01/2016.

Device

Cavafix (used for the catheterisation of vena cava)
  • Modelo / Serial
    Cavafix (used for the catheterisation of vena cava)Article Code: 4152557, 4173350, 4173759 All batchesARTG Number: 142123
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd