Events

Retiro De Equipo (Recall) de Bard Inlay Optima Ureteral Stents InLay Optima Multi-length Ureteral Stent with NiCoreNitinol/Nitinol Guidewire, InLay Optima Multi-length Ureteral Stent with HydroGlide Guidewire, InLay Optima Multi-length Ureteral Stent without Guidewire

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bard 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-2016-RN-01369-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-18
  • 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-2016-RN-01369-1
  • 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
    The food and drug administration (fda) has requested manufacturers of multi-length ureteral stents to add a statement in the warnings/precautions section of product labelling, requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal. bard has completed an internal assessment and concluded that there is the potential for a moderate severity of harm to a patient should the medical professional fail to consider the formation of a knot if significant resistance is encountered during attempts at removal. bard is including additional warning/precaution for all of bard’s multi-length ureteral stents.
  • Acción
    Bard is including additional warning/precaution for all of Bard’s multi-length ureteral stents: Formation of knots in multi-length ureteral stents may occur. This may result in injury to the ureter during removal and/or the need for additional surgical intervention. The presence of a knot should be considered if significant resistance is encounter during attempts at removal. Users are advised to follow the above warning/precaution for the stock they currently hold. Any stock purchased after November 15, 2016 is expected to have the above warning/precaution statement in the labelling. This action has been closed-out on 18/05/2017.

Device

Bard Inlay Optima Ureteral Stents InLay Optima Multi-length Ureteral Stent with NiCoreNitinol/Nit...
  • Modelo / Serial
    Bard Inlay Optima Ureteral StentsInLay Optima Multi-length Ureteral Stent with NiCoreNitinol/Nitinol GuidewireProduct Codes: 786400, 786600, 786700, 786800InLay Optima Multi-length Ureteral Stent with HydroGlide GuidewireProduct Codes: 787400, 787600, 787700, 787800InLay Optima Multi-length Ureteral Stent without GuidewireProduct Codes: 788400, 788600, 788700, 788800ARTG Number: 235658
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd