Events

Retiro De Equipo (Recall) de Edwards Lifesciences Vent Catheter

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Edwards Lifesciences 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-2014-RN-01106-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-10-14
  • 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-2014-RN-01106-1
  • 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
    Edwards lifesciences has identified a potential patient safety risk which may occur during the use of venting catheters. the malleable stylet which aids during insertion of the vent catheter is coated with a white plastic. the white plastic on the stylet has the potential to become damaged through interaction with the hard plastic suction adapter on the vent catheter. this can result in the disruption of the white plastic coating on the stylet. there is an increased chance of generating particulate if the stylet is withdrawn with sharp bends and/or reinserted into the vent catheter. reinsertion may lead to an increased potential for particulate to enter the vasculature.
  • Acción
    Edwards is adding the following additional warnings to the instruction for use: - Do not reinsert the stylet after initial removal. If repositioning of the vent catheter is necessary a new device must be used. - Check the stylet for damage during removal from the vent catheter. If the stylet appears damaged, discontinue retraction and remove the vent catheter and stylet together. - The device is designed and intended for use with suction only. Customers are advised that the customer letter needs to be passed on to all those within their organization to understand the changes that Edwards has made to the instruction for use and contraindication. This action has been closed-out on 18/03/2016.

Device

Edwards Lifesciences Vent Catheter

Manufacturer

Edwards Lifesciences Pty Ltd