Events

Retiro De Equipo (Recall) de EPILOR SYRINGE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECTON DICKINSON CANADA INC..

¿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
    100551
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-09-06
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Bd has received several reports indicating that the plunger of the 7 ml bd epilor plastic bd luer-lok loss of resistance syringe (lor) may stall or stick when travelling within the syringe. this may prevent the user from detecting a loss of resistance upon entering the epidural space. if this occurs the user may continue to advance the syringe and needle through the epidural space and the dura into the spinal canal/intrathecal space resulting in a spinal anesthesia instead of an epidural anesthesia. there have been no reports of harm to patients. date the event was first identified: 06/19/2013. bd has received complaints from customers indicating that product has exhibited higher than normal resistance in the 7ml epilor syringe. there have been a total of 7 complaints for related events in the last 3 fiscal years.

Device

EPILOR SYRINGE
  • Modelo / Serial
    Model Catalog: 405198 (Lot serial: >10 contact manufacturer); Model Catalog: 405291 (Lot serial: >10 contact manufacturer); Model Catalog: 406078 (Lot serial: >10 contact manufacturer)
  • Descripción del producto
    7 mL BD Epilor plastic BD Luer-Lok LOR Syringe (Bulk non-sterile & sterile single use)
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.