Events

Retiro De Equipo (Recall) de Bard Max-Core Disposable Core Biopsy Instrument

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-2015-RN-00330-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-04-13
  • 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-2015-RN-00330-1
  • 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 identified potential self-activation issues with the instrument during use that may pose an incremental increase in the risk associated with biopsy procedures. this includes prolonging the procedure, requiring the use of an additional device, or minor tissue injury to the patient if the device fails to fire. potential self-activation, may potentially lead to inadvertent injury to deep tissue or structures, blood vessels or adjacent critical organs. in addition, a used device may pose an incremental risk of blood borne contamination to the user if self-activated. in the event this occurred, the patient or user may require urgent medical or surgical intervention and the user is to follow facility procedures for inadvertent needle sticks or injury.
  • Acción
    Bard Australia is requesting the customers to quarantine and stop using the affected product. Bard Australia is arranging for any affected product to be returned and replaced. This action has been closed-out on 1/06/2016.

Device

Bard Max-Core Disposable Core Biopsy Instrument
  • Modelo / Serial
    Bard Max-Core Disposable Core Biopsy Instrument Product Code: MC 1820Lot Numbers: REYA2017 & REYC2853ARTG number: 180984
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd