Events

Retiro De Equipo (Recall) de Groshong NXT PICC Connector (used to repair the damaged external segment of a catheter)

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-00555-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-04-28
  • 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-00555-1
  • 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 access systems has received reports involving an incorrect connector colour indicated on the product labelling for specific lots of the replacement connector for groshong nxt picc (for use with groshong nxt, 5 fr. dual-lumen picc). the case label for the specific lot incorrectly identified the connector colour as “white”. the connector is red and is correctly identified by the unit label as “red”.
  • Acción
    Bard is advising users to be aware of the issue. The affected product remains safe to use and there is no requirement to return the affected product. This action has been closed-out on 25/01/2017.

Device

Groshong NXT PICC Connector (used to repair the damaged external segment of a catheter)
  • Modelo / Serial
    Groshong NXT PICC Connector (used to repair the damaged external segment of a catheter) Product Code: 7812500 Lot Number: REVH0705ARTG Number: 136492
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd