Events

Retiro De Equipo (Recall) de LMA MAD Nasal Intranasal Mucosal Atomisation Device (used for intranasal drug delivery)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Teleflex 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-2016-RN-01420-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-11-03
  • 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-2016-RN-01420-1
  • 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
    It has been identified that lma mad nasal intranasal mucosal atomisation device may not deliver a fully atomised plume of medication. teleflex medical has received complaints that the affected batches produced a straight stream instead of an atomised spray. the failure of the device to deliver an atomised plume may impair the effectiveness of the medication with which it is used. this can lead to serious injury or death in certain emergency situations, such as where the device is used in an off-label manner for needle-free delivery of drugs for reversal of life threatening narcotic overdose, reversal of life threatening hypoglycaemia, or treatment of epileptic seizures. this delivery issue can also occur when the device is used with medications that are intended for intranasal delivery.
  • Acción
    Teleflex is advising customers to immediately quarantine affected stock and not to use or distribute this stock. Teleflex will arrange for the return of stock and will issue credit for returned stock.

Device

LMA MAD Nasal Intranasal Mucosal Atomisation Device (used for intranasal drug delivery)
  • Modelo / Serial
    LMA MAD Nasal Intranasal Mucosal Atomisation Device (used for intranasal drug delivery)SAP/Catalogue Number: MAD300Batch Number: 160200ARTG Number: 228140
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd