Events

Retiro De Equipo (Recall) de Smiths Medical Epidural Minipack Systems

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Smiths Medical International Ltd (UK).

¿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
    15637
  • Fecha de inicio del evento
    2013-11-13
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Smiths Medical Australasia Pty Ltd, c/o KPMG, KPMG Centre, 18 Viaduct Harbour Avenue, Auckland
  • Causa
    The wording in the current ifu states : "if resistance is felt upon withdrawal, consult current medical literature for specific techniques". this is to be replaced by : "if resistance is felt or if the catheter stretches excessively on withdrawal, cease removal. never exert excessive force as this may compromise the integrity of the catheter. if clinically appropriate, reposition the patient (flex or extend, sit up or lay down) and slowly withdraw the catheter. if further resistance, repeat step and/or allow the patient to relax for several minutes/hours and attempt to remove later. if unable to remove, consult anesthetist. after removal, examine the catheter to ensure that the entire catheter with tip is intact. should the tip not be intact, consult the anesthetist".
  • Acción
    Instructions for use to be updated

Device

Smiths Medical Epidural Minipack Systems

Manufacturer

Smiths Medical International Ltd (UK)