Events

Retiro De Equipo (Recall) de Prelude SNAP Splittable Sheath IntroducerVascular Introducer Kit

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Merit Medical 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-01511-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-22
  • 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-01511-1
  • 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
    Merit medical systems, inc. is conducting a recall of specific lots of prelude snap splittable sheath introducers due to an intermittent failure of the splittable hub. merit medical has received complaints indicating that the wings on certain lots of the prelude snap have broken off the sheath hub during splitting. this will likely result in a minor delay in procedure. although rare, this could also result in a pacing lead/catheter displacement, air embolus, or minor hemorrhage. merit has received no reports of patient harm or injury as a result of this issue.
  • Acción
    Users are advised to check inventory for affected devices and discontinue their use. Affected stock should be returned to Merit Medical.

Device

Prelude SNAP Splittable Sheath IntroducerVascular Introducer Kit
  • Modelo / Serial
    Prelude SNAP Splittable Sheath IntroducerVascular Introducer KitMultiple Catalogue and Lot Numbers AffectedARTG 278434
  • Manufacturer
    Merit Medical Australia Pty Ltd

Manufacturer

Merit Medical Australia Pty Ltd