Events

Retiro De Equipo (Recall) de Spinocath G22 / G27 (Spinal anaesthesia kit)

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-2016-RN-01228-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-09-21
  • 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-2016-RN-01228-1
  • 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
    During internal quality checks b. braun discovered that the certain spinocath articles may have holes in the pvc film of the sterile barrier system. there is a risk that microorganisms may penetrate the sterile barrier through the holes in the pvc barrier. thus, contamination is possible and may pose a risk to the patient. the risk of a clinically significant infection has been assessed as low but cannot be excluded. to date no harm or any other adverse patient outcome associated with this issue has been reported.
  • Acción
    B. Braun is advising users to inspect stocks and destroy all units from the affected article code. Credit will be provided for all unused/destroyed stock. Records of previous patients should be reviewed and any potentially related infections reported to B. Braun.

Device

Spinocath G22 / G27 (Spinal anaesthesia kit)
  • Modelo / Serial
    Spinocath G22 / G27 (Spinal anaesthesia kit)Article Number: 4517725All batches affectedARTG Number: 148912
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd