MAUDE Adverse Event Report: TELEFLEX NASAL ATOMIZATION DEVICE; ATOMIZER

Device Problem Component Missing (2306)

Patient Problem Injury (2348)

Event Type  Other  

Event Description

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).

• Brand Name: NASAL ATOMIZATION DEVICE
• Type of Device: ATOMIZER
• Manufacturer (Section D): TELEFLEX
• MDR Report Key: 6050407
• MDR Text Key: 58311621
• Report Number: MW5065552
• Device Sequence Number: 1
• Product Code: CCQ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 07/07/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1