Events

Retiro De Equipo (Recall) de Bard DuaLok Breast Lesion Localization Wire

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-2014-RN-00946-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-29
  • 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-2014-RN-00946-1
  • 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 that some product code and lot number combinations may be at risk of having portions of the wire protruding from the packaging, thus representing a breach of sterile barrier. an exposed bard dualok breast lesion localisation wire has the potential to cause an inadvertent mid penetrating or laceration injury during handling of the packaging. the use of a bard dualok breast lesion localisation wire, after a portion of the wire has breached the sterile barrier, could potentially pose an incremental risk of harm including complications associated with localised or systemic infection which may require medical intervention to preclude a serious injury.
  • Acción
    Customers are advised to not use or further distribute any affected product and to remove any identified product from their shelves. Bard is also advising to closely monitor patients who are known to have been treated utilising the affected localisation wires and may still be at risk of developing infectious complications. Medical management should be at the discretion of the treating physician. This action has been closed-out on 01/03/2016.

Device

Bard DuaLok Breast Lesion Localization Wire
  • Modelo / Serial
    Bard DuaLok Breast Lesion Localization Wire Part Numbers: LW0037, LW0057, LW0077, LW0107 & LW0137Multiple lot numbersARTG number: 135463
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd