Events

Rappel de Codman Neuro EDS 3 CSF External Drainage Systems (indicated for draining cerebrospinal fluid (CSF) and other fluids when the insertion of a permanent internal shunt is not indicated)

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

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-2014-RN-01009-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-09-22
  • 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-2014-RN-01009-1
  • 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 tubing within the system that drains csf may leak or disconnect from the joints. leakage and tube separations may result in over- or under-drainage of csf from the ventricular system or introduction of air into the ventricular system (pneumocephalus). this may result in collapsed ventricles, subdural bleeding, or an inability to properly control elevated intracranial pressure. the tubing disconnection or leakage may also increase the risk of ventriculitis. if undetected or untreated each of these events may cause severe brain injury, which may lead to coma, stroke or death. these systems are most often used on neurocritical care floors and these issues are likely to be detected immediately.
  • Action
    Johnson & Johnson Medical Pty Ltd (JJM) is issuing a two stage recall action to mitigate the risk of shortage for these devices in the market place. STAGE 1 - INFORM: Inform customers regarding the product issues and what actions need to be undertaken in the interim. STAGE 2 - RECALL: Customers should return affected product to JJM once they have sourced alternate product. In the case where no substitute drainage system is immediately available, the EDS 3 System may continue to be used until an alternative product can be obtained. Manipulation of tubing should be minimised and extra vigilance (identified in the customer letter) is required for early detection of leakage and/or disconnection. After the alternative products have been sourced by customers, affected products should be quarantined for returning it to JJM. This action has been closed-out on 28/02/2018,

Device

Codman Neuro EDS 3 CSF External Drainage Systems (indicated for draining cerebrospinal fluid (CSF...
  • Modèle / numéro de série
    Codman Neuro EDS 3 CSF External Drainage Systems (indicated for draining cerebrospinal fluid (CSF) and other fluids when the insertion of a permanent internal shunt is not indicated)EDS 3CSF External Drainage System with Ventricular CatheterPart number: 82-1730ARTG: 123236EDS 3CSF External Drainage System (no Ventricular Catheter)Part number: 82-1731ARTG:122785Lumbar Drainage Catheter Kit II with EDS 3System Part number: 82-1738All lot numbers affectedARTG: 123489
  • Classification du dispositif
    Neurological Devices
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia