Retiro De Equipo (Recall) de 2-Way Foley Catheters and 2-Way Council Tip Foley Catheters (used for urinary drainage)Distributed between June 2013 to June 2015

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bard 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-2015-RN-01254-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-22
  • País del evento
  • Fuente del evento
    DHTGA
  • 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
    Bmd has identified that the instructions for use (ifu) included with the affected products provide the incorrect inflation volume. the inflation volume provided on the catheter’s valve cap does state the correct inflation volume. the ifu contains a chart entitled recommended inflation volumes with incorrect volumes. the inflation volume provided on the catheters valve cap does state the correct inflation volume.If the user follows the ifu and under inflates the balloon, the patient may experience some form of urine bypass due to the poor seating of the balloon in the bladder.
  • Acción
    Bard is providing users with the correct inflation volumes for the affected products. This action has been closed-out on 30/08/2016.

Device

  • Modelo / Serial
    2-Way Foley Catheters and 2-Way Council Tip Foley Catheters (used for urinary drainage)Distributed between June 2013 to June 2015Multiple product and catalogue numbers affectedARTG Number: 158417
  • Manufacturer

Manufacturer