Events

Retiro De Equipo (Recall) de Flocare Gastrotomy Tubes (G-tube) ENFit connector

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Nutricia Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-00725-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-13
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00725-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    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