Events

Retiro De Equipo (Recall) de PORT-A-CATH II DUAL LUMEN SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SMITHS MEDICAL CANADA LTD. (SIMS).

¿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
    24072
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-09-06
  • 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
    Since august 2009 smiths medical has received a total of 3 complaints regarding the introducer sheath and the introducer opening being too small for the width of the catheter experienced with port-a-cath and port-a-cath ii implantable venous and arterial access systems and introducer sets. there have been no reports of patient injury or death associated with this issue. investigation of this issue has identified the root cause to be related to the incorrect size introducer being used in several lots of finished goods. an in-depth investigation concluded that the incorrect introducer size was limited to 1 component part (from st. jude medical) which were put into production of 36 smiths medical finished goods lot numbers.

Device

PORT-A-CATH II DUAL LUMEN SYSTEM
  • Modelo / Serial
    Model Catalog: 21-8052-24 (Lot serial: 1971572)
  • Descripción del producto
    Port-A-Cath II Implantable Venous Access System
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Smiths Group Plc
  • Source
    HC