Events

Rappel de Epidural Minipack Systems (Epidural anaesthesia kit)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smiths Medical Australasia Pty Ltd.

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
    RC-2013-RN-01154-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-08
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01154-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer is updating the instructions for use (ifu) for users should they experience difficulties removing the catheter during procedure.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 the anaesthetist. after removal, examine the catheter to ensure that the entire catheter with tip is intact. should the top not be intact, consult the anaesthetist".
  • Action
    Smiths Medical is providing users with updated Instructions for Use (IFU) which includes the updated instructions.

Device

Epidural Minipack Systems (Epidural anaesthesia kit)
  • Modèle / numéro de série
    Epidural Minipack Systems (Epidural anaesthesia kit)Product Number: 100/391/116ARTG Number: 167342
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd