Events

Rappel de Smiths Medical Epidural Minipack Systems

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Smiths Medical International Ltd (UK).

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    15637
  • Date de mise en oeuvre de l'événement
    2013-11-13
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Smiths Medical Australasia Pty Ltd, c/o KPMG, KPMG Centre, 18 Viaduct Harbour Avenue, Auckland
  • Cause
    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".
  • Action
    Instructions for use to be updated

Device

Smiths Medical Epidural Minipack Systems

Manufacturer

Smiths Medical International Ltd (UK)