Events

Retiro De Equipo (Recall) de Niti-S Biliary Covered Stent (Flare-Type) Nagi/Pseudocyst 10mm x 3cm

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Pyramed 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-2013-RN-00615-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-06-27
  • 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-2013-RN-00615-1
  • 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 manufacturer has identified that there is a potential problem with the loosening of the y connector on the hub of the delivery sheath which is outside the patient's body during delivery of the stent.The outer sheath and y connector should be adjoined each other using glue as well as screw compression, however the gluing process was skipped in some cases with the affected lot number during manufacturing.
  • Acción
    Pyramed is asking customers to return the affected stock for replacement with unaffected stock.

Device

Niti-S Biliary Covered Stent (Flare-Type) Nagi/Pseudocyst 10mm x 3cm
  • Modelo / Serial
    Niti-S Biliary Covered Stent (Flare-Type) Nagi/Pseudocyst 10mm x 3cm Model number: BS1003FWLot number: 13D1394D3EB780 Expiry date: 2016-04ARTG number: 130531
  • Manufacturer
    Pyramed Pty Ltd

Manufacturer

Pyramed Pty Ltd