Events

Retiro De Equipo (Recall) de EnCor Probes (used for breast biopsies)

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-2016-RN-00490-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-22
  • 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-00490-1
  • 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
    Bard peripheral vascular (bpv) has confirmed that the affected lot numbers may be at risk of having an incorrect sample trap assembly. a portion of the affected lots may contain units with incorrect sample trap assemblies affixed to the probe inside the product tray (a lateral assembly instead of an upright assembly). the labelling on the outer product carton and inside packaging tray is correct. specifically, the issue is that the incorrect sample trap assembly contains shorter vacuum tubing and no clear tray cover.The potential harm associated with attempting to use this device labelled for upright use may result in the sample trap assembly being filled with fluid during use and when removing the sample collection tray (basket), the sample(s) may fall out of the collection tray because of the lack of a cover.
  • Acción
    Bard is advising users to inspect the affected lots before use to ensure the correct trap assembly is affixed to the probe. This action has been closed-out on 30/01/2017.

Device

EnCor Probes (used for breast biopsies)
  • Modelo / Serial
    EnCor Probes (used for breast biopsies)Biopsy Probe – 10g VerticalEnd Item Code: ECP0110GVLot Numbers: VT14G0223, VT15F0266, VT15G0345, VT15K0439, VT15L0482, VT15M0572Biopsy Probe – 12g VerticalEnd Item Code: ECP0112GVLot Number: VT15E0244ARTG Number: 154530
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd