Events

Rappel de NIO-A device (Automatic intraosseous infusion device that provides rapid, safe and easy intravascular access through the bone marrow)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Aero Healthcare.

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-2016-RN-01138-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-16
  • 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-2016-RN-01138-1
  • 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
    During the operation of the nio-a, the needle was not released from the device as expected. the device was placed on the floor and after several minutes the needle was released spontaneously.As the device is intended to penetrate the bone into the marrow cavity, it is designed in such way that the needle is released intensely due to a compressed spring force. spontaneous release of the needle from the device may result in serious injury of the patient, caregiver or any of the surrounding people.This action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • Action
    Aero healthcare is advising users to return the affected units. This action has been closed-out on 26/05/2017.

Device

NIO-A device (Automatic intraosseous infusion device that provides rapid, safe and easy intravasc...
  • Modèle / numéro de série
    NIO-A device (Automatic intraosseous infusion device that provides rapid, safe and easy intravascular access through the bone marrow)Lot Number: 160024ARTG Number: 145376
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare