Events

Rappel de Flocare Gastrotomy Tubes (G-tube) ENFit connector

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Nutricia 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-2017-RN-00725-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-13
  • 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-2017-RN-00725-1
  • 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
    Nutricia has received reports that the connector from the flocare g-tube enfit will, in in some occasions, detach. this situation generally occurs while disconnecting the enfit g-tube from the enfit feeding set or enfit syringe. if the connector is separated from the g-tube enfit, leakage of nutrition or spillage may occur resulting in:- an interruption or delay in therapy. when this situation remains unnoticed for a prolonged period of time, the health of a volume dependent patient can be affected due to under feeding.- a risk of abdominal burns caused by spillage of gastric contents.
  • Action
    Nutrica is advising users that in order to minimise the risk of separation, they are to 1) avoid the application of excessive force or overtighten the ENfit connectors, 2) keep the ENFit connectors as clean as possible from residual nutrition and 3) flush/clean the threads of the ENFit connectors routinely to remove residual nutrition. In the event of separation, users are advised to close the quick release clamp immediately and request a suitable adaptor from Nutricia to use in place of the ENFit end. The Medicina Trainsition Adaptor will be provided and users are advised to refer to their recall letter for its proper use.

Device

Flocare Gastrotomy Tubes (G-tube) ENFit connector
  • Modèle / numéro de série
    Flocare Gastrotomy Tubes (G-tube) ENFit connectorFlocare Gastrostomy tube (G-tube) Ch10 - ENFitSKU: 594814Flocare Gastrostomy tube (G-tube) Ch14 - ENFitSKU: 594815Flocare Gastrostomy tube (G-tube) Ch16 - ENFitSKU: 594816Flocare Gastrostomy tube (G-tube) Ch18 - ENFitSKU: 594817Flocare Gastrostomy tube (G-tube) Ch20 - ENFitSKU: 594818All BatchesARTG Number: 120000
  • Manufacturer
    Nutricia Australia Pty Ltd

Manufacturer

Nutricia Australia Pty Ltd
  • Source
    DHTGA