MAD NASAL SYRINGE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-07 for MAD NASAL SYRINGE manufactured by Teleflex Medical De Mexico S. De R. L. De C.v..

Event Text Entries

[132567967] Concern about intranasal atomizer design that uses iv compatible connection. We are seeing a move to use more intranasal meds (eg midazolam, ketamine, fentanyl, dexmedetomidine). The in administration is either by? Drops? Or atomized. Atomized drug is given with a mad nasal syringe tip atomizer. The issue is that the mad nasal systems has a female luer locker/pressure fit design that necessitates use of an iv syringe for a med meant to be given in. Note there are mad atomizer products that have an integral syringe with a? Spike? To remove drug from an iv vial. (made by teleflex) that also used iv compatible connections. (pictures attached). This obviously makes it a concerning problem whenever someone prepares a nonparental drug in an iv compatible syringe. Additionally, if pharmacy were to prepare the drug as a ready to use unit dose syringe- we would need to dispense as an iv syringe of med so the atomizer could be used. This certainly violates the rule about using iv syringes for nonparenteral routes. Pharmacy could not dispense with the mad nasal tip attached as there is no? Cap? On the atomizer tip device. Pictures attached, we have not yet decided on how best to build safeguards when pharmacy prepares beyond a warning label. Medication administered to or used by patient: no. (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5082906
• MDR Report Key: 8227563
• Date Received: 2019-01-07
• Date of Report: 2009-01-07
• Date Added to Maude: 2019-01-08
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: MAD NASAL SYRINGE
• Generic Name: NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)
• Product Code: CCQ
• Date Received: 2019-01-07
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TELEFLEX MEDICAL DE MEXICO S. DE R. L. DE C.V.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-01-07