Events

Retiro De Equipo (Recall) de Left Double Lumen Endobronchial Tube with Parker Flex-Tip

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-00258-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-03-03
  • 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-00258-1
  • 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
    An overseas complaint has been received from a physician where the product was not functioning as intended for single lung ventilation. the physician had an experience where after full intubation isolation was not successful when the physician turned the patient on his side to begin the procedure. the physician’s supposition was that the anatomy of the patient shifted in a way that occluded the bronchial lumen and prevented continued lung isolation. the physician replaced the endobronchial tube with another product and completed the procedure. to date, there has been no patient injury or harm.
  • Acción
    Device Technologies Australia (DTA) is requesting customers to immediately cease the use of affected devices. Customers are further requested to inspect and quarantine affected stock prior to their return to DTA for a replacement.

Device

Left Double Lumen Endobronchial Tube with Parker Flex-Tip
  • Modelo / Serial
    Left Double Lumen Endobronchial Tube with Parker Flex-TipProduct Codes: WL-I-PFTDL-28, WL-I-PFTDL-32, WL-I-PFTDL-35, WL-I-PFTDL-37, WL-I-PFTDL-39 and WL-I-PFTDL-41Batch Numbers: 608DL1325A, 608DL1325B, 608DL1325C, 608DL1325D, 608DL1325E and 608DL1325F ARTG Number: 170268
  • Clasificación del producto
    Anesthesiology Devices
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd