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

Model Number	35216
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Rn informed respiratory tech that pt had an audible cuff leak on pt et tube.Respiratory tech inspected pt et tube and confirmed that a cuff leak was present.Respiratory tech fixed pt cuff leak.Respiratory tech left room.Rn returned to respiratory tech within 5-10 mins stating that the cuff was leaking again.Respiratory tech used manometer to measure cuff pressure and the manometer read below the green zone.Respiratory tech then re-inflated cuff with manometer and disconnected the manometer.Respiratory tech then retested cuff pressure with manometer and the et tube cuff pressure had fallen significantly and was no longer holding a proper cuff pressure.Respiratory tech informed medical doctor who called anesthesia and assisted in et tube exchange on the pt.

• 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: 10118391
• Report Number: 10118391
• Device Sequence Number: 11362876
• Product Code: BTR
• UDI-Device Identifier: 10680651352160
• UDI-Public: (01)10680651352160
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/27/2020
• Report Date (Section F): 06/01/2020

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: 35216
• 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
• Patient Weight: 95
• Date Report Sent to FDA: 06/01/2020