NASAL ATOMIZATION DEVICE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-20 for NASAL ATOMIZATION DEVICE manufactured by Teleflex.

Event Text Entries

[58311621] I'm the outpatient pharmacy manager at (b)(6) hospital. I'm reporting an issue with a device, the mad nasal intranasal mucosal atomization device. We dispense this device to outpatients along with midazolam vials for intranasal administration to treat seizures. We have had 2 pts report that the device they received from us was missing the vial adapter piece. Without this piece the midazolam vial could not be punctured and therefore, the medication not administered. Both families had another device to use so the missing vial adapter did not result in a missed dose. Last week we discovered another device was missing the vial adapter cover when one of our employees was stocking the devices and was poked by the vial adapter. I have reported this to the vendor. The picture has the vial adapter (blue) but is missing the cover. Also the f/u letter i received from teleflex after reporting the missing cover. We have reviewed our current stock and didn't find any other devices with missing covers or vial adapters. I've contacted or attempted to contact the parents of pts who have received the device from us recently and asked them to examine their devices for missing vial adapters. (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5065552
• MDR Report Key: 6050407
• Date Received: 2016-10-20
• Date of Report: 2016-07-07
• Date Added to Maude: 2016-10-24
• 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: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: NASAL ATOMIZATION DEVICE
• Generic Name: ATOMIZER
• Product Code: CCQ
• Date Received: 2016-10-20
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TELEFLEX

Device Sequence Number: 2

• Brand Name: NASAL ATOMIZATION DEVICE
• Generic Name: ATOMIZER
• Product Code: CCQ
• Date Received: 2016-10-20
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: TELEFLEX

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-10-20