MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA ATOMIZATION; NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)

Model Number IPN048830

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2019

Event Type  malfunction  

Event Description

I was attempting to administer intranasal fentanyl and the atomizer failed to turn the medication into the mist for inhalation.The medication instead dripped out of the atomizer and down the patient's shirt.

• Brand Name: LMA ATOMIZATION
• Type of Device: NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 9347120
• MDR Text Key: 167153088
• Report Number: 9347120
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN048830
• Device Catalogue Number: MAD140OS
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1095 DA