Events

Rappel de Multi Lumen and Pressure Injectable Central Venous 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 Mayo Healthcare 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-2014-RN-00613-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-06-18
  • 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-00613-1
  • 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
    There is a low level of occurrence (<0.02%) of the lumen exit and lumen size on the extension line being misprinted on central venous catheters (cvc). as an example, the distal lumen may be printed with the word 'medial 18 ga' instead of 'distal 16ga'. misprinted labelling can cause user dissatisfaction with flow rates (ml/hr) in the case the lumen would be expected to perform as labelled for high volume gravity infused (the mismarked 16ga lumen) since in reality this is an 18ga lumen and gravity flow is approximately half (1/2) the expected flow rate in ml/hr for a 16ga lumen. this could result in a worst case scenario clinical intervention to use a pressure bag or pump to achieve adequate flow rates. the colour coding of all hubs is correct and corresponds to the arrow system.
  • Action
    Mayo Healthcare Pty Ltd is advising their customers to be aware of the incorrect labelling.

Device

Multi Lumen and Pressure Injectable Central Venous Catheters
  • Modèle / numéro de série
    Multi Lumen and Pressure Injectable Central Venous CathetersAffected Lot Numbers: 71F14A0329, RF1082062, 71F13H0637, ZF3063390, 71F14C0868, ZF1124891, ZF3051182, 71F13K0810, 71F13J1589, 71F14C0173, ZF2052625, 71F13H0972, 71F13K1389, 71F13K1796, 71F13K0429, ZF2111681, 71F13H1291, 71F13L0166, 71F14A0120, 71F13K1808, 71F14A1404, 71F13K0325, 71F13L1212, 71F14B0386, ZF3052590, RF0127942, 71F13K1625, ZF2123457, 71F14B0029, RF1069981, RF0087867, ZF3040526, 71F14B0377 ARTG Number: 142543
  • Manufacturer
    Mayo Healthcare Pty Ltd

Manufacturer

Mayo Healthcare Pty Ltd