Events

Retiro De Equipo (Recall) de Bard Max-Core Disposable Core Biopsy Instrument Biopsy Gun Dispos MaxCore 14gx10cm Biopsy Gun Dispos MaxCore 16gx16cm Biopsy Gun Dispos MaxCore 18gx16cm Biopsy Gun Dispos MaxCore 18gx20cm ARTG Number: 174371

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-2017-RN-01238-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-10-03
  • 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-2017-RN-01238-1
  • 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
    The manufacturer, bard peripheral vascular has identified that specific product code / lot number combinations may be at risk of having issues related to proper functioning of the device. this includes difficulty with priming and firing, failure to obtain tissue sample, and in some instances self-activating after priming.In most cases, the identified issues (failure to prime, failure to fire, failure to obtain a sample) will lead to a varying degree of user dissatisfaction or may be associated with a prolonged procedure or minor tissue injury. although unlikely to lead to user or patient injury consistent with a serious adverse event, the unpredictable nature of self-activation presents some risk to use of the product. there is no residual risk to users or patients that used the product previously without incident.
  • Acción
    1. Bard is advising users to inspect stock and quarantine any remaining units of the affected batches. 2. Affected stock can be returned to Bard.

Device

Bard Max-Core Disposable Core Biopsy Instrument Biopsy Gun Dispos MaxCore 14gx10cm Biopsy Gun Dis...
  • Modelo / Serial
    Bard Max-Core Disposable Core Biopsy InstrumentBiopsy Gun Dispos MaxCore 14gx10cmProduct Code: MC1410Lot Numbers: REBN2123, REBP1199 and REBP1807Biopsy Gun Dispos MaxCore 16gx16cmProduct Code: MC1616Lot Number: REBP1420Biopsy Gun Dispos MaxCore 18gx16cmProduct Code: MC1816Lot Number: REBN0342Biopsy Gun Dispos MaxCore 18gx20cmProduct Code: MC1820Lot Number: REBQ1014ARTG Number: 174371
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd