Events

Rappel de Contact Detach Infusion Sets ( used in conjunction with a pump to deliver a continuous dose of insulin) Manufactured prior to May 2014

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Australasian Medical & Scientific 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-2015-RN-00703-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-07-31
  • 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-2015-RN-00703-1
  • 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 has identified a slight increase in reported cases of the steel needle breaking during use for infusions sets manufactured prior to may 2014. in a small sub set of these reported cases, this needle breakage has led to hospitalisation for the management of glucose levels and/or treatment for removal of the needle. needle breakage can result in the interruption of insulin delivery and can cause hyperglycaemia, which if left untreated, can result in diabetic ketoacidosis (dka). in addition to the interruption of insulin, a needle remaining in the body might, in rare cases, require surgical removal if the needle does not itself migrate to the surface where it can be removed with a pair of tweezers.
  • Action
    In the event consumers wish to carry on with using the old needle they are reminded to follow the current IFU along with specific additional instructions in the customer letter; OR if they prefer users (including members of the public) can phone AMSL for replacement with unaffected stock. This action has been closed-out on 15/08/2016.

Device

Contact Detach Infusion Sets ( used in conjunction with a pump to deliver a continuous dose of in...
  • Modèle / numéro de série
    Contact Detach Infusion Sets ( used in conjunction with a pump to deliver a continuous dose of insulin)Manufactured prior to May 2014Multiple Lot Numbers – see attached listARTG Number: 116234
  • Manufacturer
    Australasian Medical & Scientific Ltd

Manufacturer

Australasian Medical & Scientific Ltd