Events

Retiro De Equipo (Recall) de AngioDynamics Morpheus Smart PICC CT (Central venous catheters)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medical Specialties 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-2015-RN-00263-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-23
  • 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-2015-RN-00263-1
  • 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
    Angiodynamics, the manufacturer of morpheus smart picc ct kits is conducting a medical device recall on specific kit / lot numbers of power injectable picc catheters. based on a review of complaints, angiodynamics has determined that the power injectable picc catheters contained in these kits exhibit a higher than anticipated rate of extension tube fracture or leakage. use of the picc catheters that are subject to this recall may have an increased incidence of extension tube fractures or leakage which would require replacement of the picc catheter.
  • Acción
    Customers are advised to segregate affected stock to a secure location for return to the Medical Specialties Australia. This action has been closed-out on 1/06/2016.

Device

AngioDynamics Morpheus Smart PICC CT (Central venous catheters)
  • Modelo / Serial
    AngioDynamics Morpheus Smart PICC CT (Central venous catheters)Catalogue number:12102602 Lot number: 583841 Catalogue number: 12102605Lot number: 588129Catalogue number:12102802Lot number: 601006 Catalogue number:12102813Lot number: 603510ARTG number: 204787
  • Manufacturer
    Medical Specialties Australia Pty Ltd

Manufacturer

Medical Specialties Australia Pty Ltd
  • Source
    DHTGA