Events

Retiro De Equipo (Recall) de Bard EnCor Needle Guide Insert (part of the EnCor Breast Biopsy Probe)

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-01101-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-23
  • 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-01101-1
  • 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 has identified that the affected lot numbers may be at risk of having an incorrect encor accessory needle guide insert. specifically, a smaller diameter (12g) insert may be contained within the larger (10g) package. this will render the device unusable and the user will need to replace the incorrect needle guide with one of the correct size. to date, bard have received 6 complaints from customers that have received the smaller product in error; none have resulted in an adverse event to patient or loss of functionality of the encor probe.
  • Acción
    Bard is advising users that if the incorrect Needle Guide Insert is contained within the packaging, to utilise a new biopsy probe (12G) for the procedure. This action has been closed-out on 10/05/2017.

Device

Bard EnCor Needle Guide Insert (part of the EnCor Breast Biopsy Probe)
  • Modelo / Serial
    Bard EnCor Needle Guide Insert (part of the EnCor Breast Biopsy Probe)Item Code: ENCFINSERT10GMultiple Lot numbers affectedARTG Number: 153519
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd