Events

Retiro De Equipo (Recall) de Tracoe Twist Tracheostomy TubeSize 06

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Intersurgical 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-01321-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-20
  • 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-01321-1
  • 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
    Tracoe medical has established at primary packaging, that some obturators of one batch (size 06) can break when inserted into the outer cannula. this may result in the breakage of the obturator whilst in the patient within the tube. if this was to occur, the broken fragments would likely be inhaled into the lower respiratory tract.In the event the breakage of the obturator is not detected, the aspirated fragments may remain in the deep respiratory tract. should the fragments remain there over a longer period of time, in the worst case scenario, an inflammatory reaction in the respiratory tract can occur.
  • Acción
    Intersurgical is advising users to quarantine affected stock. Intersurgical will collect stock from affected customers and provide credit.

Device

Tracoe Twist Tracheostomy TubeSize 06
  • Modelo / Serial
    Tracoe Twist Tracheostomy TubeSize 06Reference Number: REF 306-06Batch Numbers: 1000123766, 1000124104, and 1000124346 ARTG Number 128498 (Intersurgical Australia Pty Ltd - Tube, tracheostomy, single use)
  • Manufacturer
    Intersurgical Australia Pty Ltd

Manufacturer

Intersurgical Australia Pty Ltd