Events

Retiro De Equipo (Recall) de TRACHEOSTOMY TUBES TTS WIRE REINFORCED SILICONE PEDIATRIC/NEONATAL

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
    25569
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2011-11-23
  • 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
    Smiths medical has become aware of a small number of complaints of customers experiencing difficulty disconnecting accessories from the connectors of the affected tubes. in some cases the customer was unable to disconnect the accessory or excessive force lead to decannulation of the tube and an emergency tracheostomy tube change was required. if the accessory is correctly connected to the affected tubes then there will be no issue with disconnection.

Device

TRACHEOSTOMY TUBES TTS WIRE REINFORCED SILICONE PEDIATRIC/NEONATAL
  • Modelo / Serial
    Model Catalog: 67P040 (Lot serial: 1631477 through 1923406); Model Catalog: 67N030 (Lot serial: 1631477 through 1923406); Model Catalog: 67N035 (Lot serial: 1631477 through 1923406); Model Catalog: 67P055 (Lot serial: 1631477 through 1923406); Model Catalog: 67P050 (Lot serial: 1631477 through 1923406); Model Catalog: 67P045 (Lot serial: 1631477 through 1923406); Model Catalog: 67N025 (Lot serial: 1631477 through 1923406); Model Catalog: 67P035 (Lot serial: 1631477 through 1923406); Model Catalog: 67P030 (Lot serial: 1631477 through 1923406); Model Catalog: 67N040 (Lot serial: 1631477 through 1923406); Model Catalog: 65P055 (Lot serial: 1631477 through 1923406); Model Catalog: 60PFP40 (Lot serial: 1631477 through 1923406); Model Catalog: 65P045 (Lot serial: 1631477 through 1923406); Model Catalog: 65P040 (Lot serial: 1631477 through 1923406); Model Catalog: 65P035 (Lot serial: 1631477 through 1923406); Model Catalog: 65P030 (Lot serial: 1631477 through 1923406); Model Catalog: 65P025 (Lot serial: 1631477 thr
  • Descripción del producto
    Bivona Tracheostomy Tubes TTS - Pediatric/Neonatal
  • 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