Events

Retiro De Equipo (Recall) de Endo-Scrub2 Sheaths and Tubing Set

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia 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-00295-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-03-18
  • 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-2014-RN-00295-1
  • 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 luer connector on the end of the tubing that attaches to the sheath may break off, either prior to or during use. once the connector breaks, the flow of saline to the sheath either ceases or is reduced and leakage occurs at the fracture site.
  • Acción
    Medtronic is requesting end users to inspect the luer connection for breakage at the point of use. Any broken tubing sets are to be discarded. New tubing sets will be provided to replace broken devices.

Device

Endo-Scrub2 Sheaths and Tubing Set
  • Modelo / Serial
    Endo-Scrub2 Sheaths and Tubing SetSheath Models #’s (w/ tubing): 1912000, 1912004, 1912008, 1912032, 1912033, 1912038, 1912040, 1912050Tubing Model #’s: 1912030Multiple lot numbersARTG numbers: 125734 and126694
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA