Events

Retiro De Equipo (Recall) de BMC RF Cannula

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Baylis Medical Company 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
    64250
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0879-2013
  • Fecha de inicio del evento
    2012-10-04
  • Fecha de publicación del evento
    2013-02-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-05-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115670
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Probe, radiofrequency lesion - Product Code GXI
  • Causa
    A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. the cannulas were not used on any patients, as the unsealed packages.
  • Acción
    A recall was initiated on 10/04/2012 and a letter was sent out to the distributor with a Fax-back Acknowledgment Form. The letter described the issue and provided recommendations and a contact number.

Device

BMC RF Cannula
  • Modelo / Serial
    Device Model #: 1 PMF 16-145-10CS. Lot number: PFFB 190811.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    International distribution to the country of Australia.
  • Descripción del producto
    BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.
  • Manufacturer
    Baylis Medical Company Inc.

Manufacturer

Baylis Medical Company Inc.
  • Dirección del fabricante
    Baylis Medical Company Inc., 5160 Explorer Drive #33, Mississauga Canada Ontario
  • Empresa matriz del fabricante (2017)
    Baylis Medical Company, Inc
  • Source
    USFDA