Events

Retiro De Equipo (Recall) de PORTEX ENDOTRACHEAL TUBE HOLDERS

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
    26679
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-07-09
  • 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 trend in complaints of difficulty in passing a suction catheter or locking the et tube holder in place was observed. smith medical's investigation determined that the fastener component and cylinder component on the et tube holder could cause compression of the tracheal tube when assembled together. the investigation determined that in some cases the fastener and cylinder could compress the tube enough to affect the tracheal tube inner diameter. customer feedback suggested that difficulty passing suction catheter usually occurred when a size 6fr suction catheter (or larger) was used.

Device

PORTEX ENDOTRACHEAL TUBE HOLDERS
  • Modelo / Serial
    Model Catalog: H4052 (Lot serial: >100 numbers contact mfg.); Model Catalog: H4051 (Lot serial: >100 numbers contact mfg.)
  • Descripción del producto
    Portex Endotracheal Tube Holders Sizes 2.5mm and 3.0mm
  • 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