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

Model Number	35216
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
At the beginning of shift, noted an audible cuff leak on pts ett.Volumes mismatched on vent (i.E.In = 500, out = 300).Not desaturating.Called rt to bedside.Air added to ett cuff and stopcock added to pilot balloon - has been working in cases w/ slow cuff leaks.Rts added about 20ccs to cuff w/ stopcock, still notable cuff leak.Micu team and fellow updated.Micu fellow came in and exchanged ett over a bougie.Charge rn aware.Ett info: #7.5 microcuff oronasal tube.No lot or id # on tube.Once the tube was out, re-tested cuff w/ air and it appeared intact.After ett exchange (meds included roc, etomidate, propofol), patient did require an increase in levo after dropping his blood pressure.Was temporary and we were able to down-titrate levo afterwards.

• 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: 10355409
• Report Number: 10355409
• Device Sequence Number: 2951661
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2020
• Report Date (Section F): 07/21/2020

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: 08/03/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2020
• 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: 07/21/2020