Events

Retiro De Equipo (Recall) de Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EZ-Lok

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-01095-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-09
  • 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-01095-1
  • 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 has identified that some devices from a specific lot of product have a potential breach of the sterile barrier packaging. this defect may put patients at an increased risk of an ascending urinary tract infection. symptoms of an infection could include fever, pain and burning sensation upon voiding.
  • Acción
    Bard is requesting users inspect their stocks and to quarantine affected units prior to return as per the instructions in the customer letter. If customers have used any affected product, monitor the relevant patients for symptoms and signs of localised and/or systemic infection. This action has been closed-out on 22/08/2016.

Device

Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EZ-Lok
  • Modelo / Serial
    Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EZ-Lok Catalogue Number: 154006Lot Number: NGYJ0603ARTG Number: 195134
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd