Events

Retiro De Equipo (Recall) de Ventricular Catheter Accessory Kit (used for external cerebrospinal fluid (CSF) drainage)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Integra Neurosciences 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-01139-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-29
  • 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-01139-1
  • 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
    The manufacturer has identified that there is a possibility of an incomplete seal of the product packaging in one specific lot of the ventricular catheter accessory kit. the packaging defect can impact both the inner and outer seals of the product resulting in the possibility that the sterility assurance may be compromised. to date, there have been no complaints submitted and no adverse events reported due to a compromised seal.
  • Acción
    Integra is advising users to inspect inventory and quarantine any remaining units of the affected stock. Affected product will be replaced with unaffected stock. This action has been closed-out on 16/02/2017.

Device

Ventricular Catheter Accessory Kit (used for external cerebrospinal fluid (CSF) drainage)
  • Modelo / Serial
    Ventricular Catheter Accessory Kit (used for external cerebrospinal fluid (CSF) drainage)Catalogue Number: 951303Lot Number: 0195786ARTG Number: 172182
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd