Events

Retiro De Equipo (Recall) de ARROW VASCULAR POSITIONING SYSTEM (VPS) - BEDSIDE PROCEDURE KIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por TELEFLEX MEDICAL 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
    67749
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-08-13
  • 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
    Arrow is recalling certain lots of the products referenced above due to reports clinicians have had difficulty maintaining a secure connection between the male luer of the tuohy borst adapter of the vascular positioning system stylet to the hub of the catheter. when the connection is not secure there is a possibility the connection will leak saline. this is most often discovered during initial flushing prior to insertion in which case a delay in treatment can occur while the health care provider locates a replacement device. in the unlikely event that the issue is discovered while the device is in use it could result in an inability to obtain a signal on the vps console. this would in turn necessitate removal and replacement of the catheter or an x-ray to confirm proper catheter placement.

Device

ARROW VASCULAR POSITIONING SYSTEM (VPS) - BEDSIDE PROCEDURE KIT
  • Modelo / Serial
    Model Catalog: VPS7220B (Lot serial: > 10 numbers contact mfg)
  • Descripción del producto
    ARROW INTERNATIONAL VPS ACCESS KIT WITH TUOHY BORST COMPONENT
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.