Events

Retiro De Equipo (Recall) de BD VACUTAINER PLUS PLASTIC PLASMA SEPARATOR TUBES (PST)

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
    73859
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-04-29
  • 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 product defect named "lip-out" was detected for bd vacutainer pst tubes. it consists of gaps of various sizes in the structure of the tube wall that is present at the lip of the tube. these gaps are covered by the stopper and hemogard closure so the tube can be evacuated and used for blood collection. customer complaints cite jamming of preanalytical automation (tube decappers) and leakage of blood in the specimen transport bag.

Device

BD VACUTAINER PLUS PLASTIC PLASMA SEPARATOR TUBES (PST)
  • Modelo / Serial
    Model Catalog: 367962 (Lot serial: >10 contact manufacturer); Model Catalog: 367960 (Lot serial: >10 contact manufacturer); Model Catalog: 367961 (Lot serial: >10 contact manufacturer)
  • Descripción del producto
    BD Vacutainer Plus Plastic Plasma Separator Tube (PST)
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.