Events

Rappel de Catheters with Beacon Tip Technology

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par William A Cook 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-2016-RN-00483-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-04-22
  • 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-2016-RN-00483-1
  • 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
    Cook medical has identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. the preliminary investigation has identified that environmental conditions, such as storage temperature, humidity, and the use of vaporised hydrogen peroxide (vhp) for whole-room decontamination within healthcare facilities, may be contributing to the occurrence. it is recognised that there may be other undetermined contributors to this issue and continue to investigate. potential adverse events that may occur as a result of catheter polymer degradation include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. fragments within the vascular system could result in embolisation to the heart or lungs, or occluding blood flow to end organs.
  • Action
    Cook Medical is advising users to quarantine and return any unused product.

Device

Catheters with Beacon Tip Technology
  • Modèle / numéro de série
    Catheters with Beacon Tip TechnologyMultiple products/catalogue numbers affectedAll lots affectedARTG Numbers: 137861, 154909, 153374, 153375,154911, 137861, 214869, 137911, 212573,133996, 208185, 207779
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd