Events

Rappel de Medcomp Hemo-Cath LT and Hemo-Cath ST Hemodialysis catheters

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par AA-Med 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-00693-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-08-05
  • 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-00693-1
  • 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
    Medcomp has become aware of the potential for holes developing in the silicone extension tubing of the hemo-cath catheters. during insertion, users may clamp over the guidewire which may cause initial damage to the tubing and over time this could develop into a leak.An initial crack in the tubing on the inside may propagate over time and eventually travel through the full thickness of the tubing developing into a hole that leaks.These holes may leak when the catheter is being accessed or pressurised during a treatment. the timeframe of when the holes are discovered is immediately post insertion or after several months of usage or longer.In the event a hole develops in the tubing, there is a potential for blood loss, air emboli, infection, delays in treatment and/or surgical procedure to remove and replace the device prior to continuing a dialysis treatment.
  • Action
    Users are reminded that during the insertion of the device not to clamp over the guidewire as this may initiate damage to the tubing that could progress into a leak over time. As an ongoing corrective measure, a new stylet tag with this instruction will also be included in future product. No actual product is being recalled from the Market. This action has been closed-out on 12/08/2016.

Device

Medcomp Hemo-Cath LT and Hemo-Cath ST Hemodialysis catheters
  • Modèle / numéro de série
    Medcomp Hemo-Cath LT and Hemo-Cath ST Hemodialysis catheters Product Codes: ECS1315, ECS1320, ECS1324Lot Numbers: ALLARTG Number: 172150
  • Manufacturer
    AA-Med Pty Ltd

Manufacturer

AA-Med Pty Ltd
  • Source
    DHTGA