MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67N030
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was due for a tracheostomy tube change by ears/nose/throat (ent) doctor.The fellow tested the cuff and the balloon did not deflate.Two tracheostomy tubes were tested and did not inflate, the third trach balloon inflated.This was a planned situation and the trach tube was not changed until there was a trach tube that had a balloon that inflated.The trach tubes were both: neonatal bivona tts 3.0.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• MDR Report Key: 10055611
• Report Number: 10055611
• Device Sequence Number: 14161874
• Product Code: JOH
• UDI-Device Identifier: 15021312006216
• UDI-Public: (01)15021312006216(17)231206(10)3731619
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/07/2020
• Report Date (Section F): 05/07/2020

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: 67N030
• Device Lot Number: 3731619
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2020
• 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: 05/07/2020