Events

Rappel de LMA MAD Nasal Intranasal Mucosal Atomisation Device (used for intranasal drug delivery)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Teleflex Medical Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-01420-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-11-03
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01420-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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)
  • Modèle / numéro de série
    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