MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HALYARD; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	35214
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Failed ett cuff.Patient intubated for angioedema.Single attempt passed gently using glidescope hyperangulated blade.Nothing unusual about the intubation.Tube passed easily.Cuff had immediate leak.Replaced over bougie easily.This was a 7.5 microcuff ett kept by the respiratory therapist.The tube was placed under water and inflated.Leak appears to be in the distal cuff.Pilot balloon and line appeared undamaged.

• Brand Name: HALYARD
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10118224
• Report Number: 10118224
• Device Sequence Number: 14116636
• Product Code: BTR
• UDI-Device Identifier: 10680651352146
• UDI-Public: (01)10680651352146
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2020
• Report Date (Section F): 05/13/2020

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: No Information
• Device Model Number: 35214
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/13/2020