Events

Rappel de Argyle Single Lumen Polyurethane Umbilical Vessel Catheter (Intended for short-term vascular access via umbilical vessels in neonatal patients)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Covidien 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-2013-RN-00971-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-09-13
  • 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-2013-RN-00971-1
  • 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 instructions for use was updated to address the increasing use of disinfectants containing alcohol and/or acetone to clean vascular access devices. the use of these disinfectants can cause damage to the polyurethane contained in the catheter and make it more susceptible to physical damage, which may ultimately lead to the need to replace the catheter.
  • Action
    Covidien has updated the instructions for use for polyurethane single lumen umbilical vessel catheters to include additional information on the care of the device.

Device

Argyle Single Lumen Polyurethane Umbilical Vessel Catheter (Intended for short-term vascular acce...
  • Modèle / numéro de série
    Argyle Single Lumen Polyurethane Umbilical Vessel Catheter (Intended for short-term vascular access via umbilical vessels in neonatal patients)Product IDs: 8888160325, 8888160333, 8888160341ARTG Number: 149128
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA