Events

Retiro De Equipo (Recall) de PREPSTAIN - SLIDE PROCESSOR

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
    24570
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-07-19
  • 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
    A prepstain system rack setting was incorrectly entered (during a routine preventive maintenance visit) resulting in a tube position with the wrong y offset for rack four only. specifically the y offset had the 12th position mapped to an incorrect tube. the error consisted of a single patient sample being drawn and deposited on four (4) consecutive slides: - patient specimen from tube 1 was deposited on slides 1-4. - patient specimen from tube 5 was deposited on slides 5-8. - patient specimen from tube 9 was deposited on slides 9-12. the error was introduced due to an incorrect keystroke by the bd field service engineer (fse) (human error). the incorrect rack setting led to: - patient samples which were not tested during a test run (specifically each run of 48 patient samples would include 9 patient samples that were not processed) and - incorrect reporting of patient results. the 9 patient test results (not tested) were reported from the other patient specimens.

Device

PREPSTAIN - SLIDE PROCESSOR
  • Modelo / Serial
    Model Catalog: 799-13000-00 (Lot serial: >10 contact manufacturer); Model Catalog: 799-14000-00 (Lot serial: >10 contact manufacturer); Model Catalog: 05CR000021 (Lot serial: >10 contact manufacturer); Model Catalog: 490100 (Lot serial: >10 contact manufacturer); Model Catalog: 490407 (Lot serial: >10 contact manufacturer); Model Catalog: 799-13000-00R (Lot serial: >10 contact manufacturer); Model Catalog: 799-14000-00R (Lot serial: >10 contact manufacturer); Model Catalog: 05CR00021R (Lot serial: >10 contact manufacturer)
  • Descripción del producto
    BD PrepStain AG/US-I/US-II
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.