Events

Retiro De Equipo (Recall) de BARD Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap

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-01075-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-12
  • 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-01075-1
  • 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 medical division (bmd) has identified that certain product code / lot number combinations may be at risk for having a slit defect on the package which may affect product sterility. use of a potentially non-sterile bard irrigation syringe could introduce microorganisms which may lead to a varying degree of risk including localised and/or systemic infectious complications. in the event this occurred, the patient may require medical intervention. there have been no reports of patient injuries as a result of this issue.
  • Acción
    Bard is advising users that if affected product has been used, to monitor the patient for symptoms and signs of localised and/or systemic infection. Users are advised to inspect stock and quarantine any remaining units of the affected batches for return to Bard. This action has been closed-out on 03/03/2017.

Device

BARD Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap
  • Modelo / Serial
    BARD Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and CapProduct Code: 0038460Lot Numbers: NGZD0924, NGZD4923, NGZD3989, NGZD3241Expiration dates range between April 30, 2020 and July 31, 2020ARTG Number: 137628
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd