The Therapeutic Goods Administration (TGA) of Australia has posted a medical device safety alert concerning LMA MAD Nasal Intranasal Mucosal Atomisation Device (Catalogue Number: MAD300, Batch Number: 160200), manufactured by Teleflex.
It has been identified that LMA MAD Nasal Intranasal Mucosal Atomisation Device may not deliver a fully atomised plume of medication. The manufacturer has received complaints that the affected batch 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 hypoglycemia, or treatment of epileptic seizures. This delivery issue can also occur when the device is used with medications that are intended for intranasal delivery.
The manufacturer is advising customers to immediately quarantine affected stock and not to use or distribute this stock. The manufacturer will arrange for the return of stock and will issue credit for returned stock.
For details, please refer to the TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2016-RN-01420-1
If you are in possession of the affected products, please contact your supplier for necessary actions
Posted on 7 November 2016