Events

Retiro De Equipo (Recall) de BD Epilor Plastic BD Luer-Lok Loss of Resistance (LOR) Syringe (7mL) (Used in conjunction with an epidural needle for identifying epidural space)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Becton Dickinson 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-2013-RN-00922-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-09-06
  • 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-2013-RN-00922-1
  • 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
    Bd has received complaints relating to difficulty in moving the plunger rod or the plunger rod sticking. this has the potential to prevent the anaesthetist from correctly detecting the loss of resistance upon entering the epidural space.
  • Acción
    Prior to using each syringe, it is recommended that anaesthetists ensure that there is no difficulty in moving the plunger rod and that the plunger rod does not stick. Any LOR Syringe that shows inappropriate resistance should be discarded; the procedure can then be continued by using another LOR Syringe that does not show resistance.

Device

BD Epilor Plastic BD Luer-Lok Loss of Resistance (LOR) Syringe (7mL) (Used in conjunction with an...
  • Modelo / Serial
    BD Epilor Plastic BD Luer-Lok Loss of Resistance (LOR) Syringe (7mL) (Used in conjunction with an epidural needle for identifying epidural space)Reference Number: 405291Lot Numbers: 0039440, 0154661, 0174905, 0252565, 1012200, 1124755, 1213029, 1312116, 1320204, 2286395, 2303141, 2334338, 2334339, 8277525, 8357843, 9093622 and 9149990ARTG Number: 120174
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd