Events

Retiro De Equipo (Recall) de BD Perisafe epidural mini-kit: 18 G x 3 1/2 in. Weiss needle. The catheter connector has four components: body (green), cap (white), washer (white), and gasket (grey). It is used for continuous administration of anesthesia. The product is molded and assembled by Avail, Northeast. It is then supplied to BD (Juncos, PR) where it is allocated to be packaged and sold in kits, trays, Perisafe and bulk.

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 Becton Dickinson & Company.

¿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
    34199
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0468-06
  • Fecha de inicio del evento
    2005-11-17
  • Fecha de publicación del evento
    2006-02-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43258
  • 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
    Connector, Catheter - Product Code GCD
  • Causa
    The catheter connector could not be sufficiently tightened to secure the catheter tubing.
  • Acción
    Recall letters were sent to all direct consignees and potential end users of the product on 11/17/2005. Letters were mailed via UPS second day air.

Device

BD Perisafe epidural mini-kit: 18 G x 3 1/2 in. Weiss needle. The catheter connector has four co...
  • Modelo / Serial
    Reorder Number 400273 Lot Number 5164796
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    The devices were distributed to wholesalers and hospitals nationwide. There are no international or govt accounts.
  • Descripción del producto
    BD Perisafe epidural mini-kit: 18 G x 3 1/2 in. Weiss needle. The catheter connector has four components: body (green), cap (white), washer (white), and gasket (grey). It is used for continuous administration of anesthesia. The product is molded and assembled by Avail, Northeast. It is then supplied to BD (Juncos, PR) where it is allocated to be packaged and sold in kits, trays, Perisafe and bulk.
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Dirección del fabricante
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA