Events

Retiro De Equipo (Recall) de Klikfit CT Syringe with QFT and 75cm Extension tube

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Imaxeon 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-00173-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-11
  • 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-00173-1
  • 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
    An issue has been identified with the 75cm extension tube included with the klikfit ct syringe with qft. the coil presentation of the tube causes a pull force that could dislodge or move the connected cannula which can lead to extravasation.
  • Acción
    Imaxeon is advising users to inspect stock and quarantine any remaining units. Affected stock can be returned to Imaxeon and replaced with an alternate product.

Device

Klikfit CT Syringe with QFT and 75cm Extension tube
  • Modelo / Serial
    Klikfit CT Syringe with QFT and 75cm Extension tubeCatalogue Number: ZY6022All lot numbers with an expiry date up to and including November 2020ARTG Number: 127663
  • Manufacturer
    Imaxeon Pty Ltd

Manufacturer

Imaxeon Pty Ltd
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    DHTGA