Events

Rappel de Bead Block (Embolic Bead)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies Australia 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-2015-RN-00141-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-02-25
  • 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-00141-1
  • 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 that there is contradictory labelling used for certain sizes of the bead block. the instructions for use state : “when using bead block for uterine fibroid embolisation (ufe), do not use beads smaller than 500 microns.”, the cartons containing bead block sizes 100-300 µm (bic-eb2s103) and 300-500 µm (bic-eb2s305) state: “indication: embolisation of uterine fibroids (ufe), hypervascular tumours are arteriovenous malformations (avms)”. the carton for the stated sizes of bead block is incorrectly labelled with indications for ufe. the ifu correctly states not to use beads smaller than 500 microns for ufe. the ifu correctly states not to use beads smaller than 500 microns for ufe. in the event healthcare practitioners were to follow up the ufe indication on the carton for the affected sizes without referring to the product ifu, there is a potential risk of infarction of non-targeted tissue.
  • Action
    In the short term users are advised of this issue and reminded of the correct Instructions for Use. In the longer term the manufacturer is correcting the applicable carton for Bead Block sizes 100-300 ìm (BIC-EB2S103) and 300-500 ìm (BIC-EB2S305) to remove indication for UFE. The Manufacturer is correcting the applicable carton for Bead Block sizes 100-300 ìm (BIC-EB2S103) and 300-500 ìm (BIC-EB2S305) to remove indication for UFE. Release of affected sizes will re-commence following this correction. This action has been closed-out on 31/05/2016.

Device

Bead Block (Embolic Bead)
  • Modèle / numéro de série
    Bead Block (Embolic Bead) Product Code: BIC-EB2S103 Batch Numbers: S10283, S10334, S10476, S10481 and S10765 Product Code: BIC-EB2S305 Batch Numbers: S10224, S10238, S10381, S10403, S10477, S10493, S10490, S10519, S10529, S10554, S10573, S10573, ARTG Number: 158665
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd