MAUDE Adverse Event Report: VYAIRE MEDICAL. AIRLIFE TRI-FLO SUCTION CATHETER; CATHETERS, SUCTION, TRACHEOBROCHIAL

Model Number	AIRLIFE TRI-FLO SUCTION CATHETER
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, vyaire has not received the suspect device for evaluation, a complete investigation of the defect reported by the customer could not be performed and no root cause could be determined.No further evaluation can be completed at this time.
Event or Problem Description
The customer reported that the airlife tri-flo suction catheter are not even hollowed out properly to be able to create suction.The issue occur while use on a (b)(6)-year-old tracheostomy and gastrostomy tube dependent patient which almost taken saline into his lungs.The customer confirmed that there was no patient harm.

• Brand Name: AIRLIFE TRI-FLO SUCTION CATHETER
• Common Device Name: CATHETERS, SUCTION, TRACHEOBROCHIAL
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9772030
• Report Number: 8030673-2020-00084
• Device Sequence Number: 11551726
• Product Code: BSY
• UDI-Device Identifier: 10190752145566
• UDI-Public: (01)10190752145566(11)20190110(10)0004072275
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AIRLIFE TRI-FLO SUCTION CATHETER
• Device Catalogue Number: T64C
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 1 YR