Events

Retiro De Equipo (Recall) de BD Q-SYTE

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
    38430
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-02-18
  • 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
    May fail to conform to a claim made by the manufacturer or importer relating to its performance and may be hazardous to health: the silicone column of the septum of the bd q-syte luer access split septum device is torn resulting in leakage of blood or infusate from the side holes or the remote potential for air bubbles to enter into the bloodstream if a negative pressure/vacuum situation is created. date the event was first identified: december 24 2014. description of how the event was identified: an increase in the number of complaints for this product was identified internally. note that there have been no complaints for air in the line related to the use of the device with a peripheral iv or a cvc line. there have also been no complaints for this product from canadian customers.

Device

BD Q-SYTE
  • Modelo / Serial
    Model Catalog: 385100 (Lot serial: 4128926)
  • Descripción del producto
    BD Q-SYTE LUER ACCESS SPLIT SEPTUM
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.