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

Model Number	67NFPS30
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The rn acting as scrub for the procedure tested the cuff balloon prior to procedure start and only half of the balloon inflated.
Event or Problem Description
The rn acting as scrub for the procedure tested the cuff balloon prior to procedure start and only half of the balloon inflated.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings rd.; dublin OH 43016
• MDR Report Key: 7128131
• Report Number: 7128131
• Device Sequence Number: 19225291
• Product Code: JOH
• UDI-Device Identifier: 10351688518781
• UDI-Public: (01)10351688518781(17)220309(10)3368115
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017
• Report Date (Section F): 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 03/09/2022
• Device Model Number: 67NFPS30
• Device Lot Number: 3368115
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 YR
• Patient Weight: 6
• Date Report Sent to FDA: 12/07/2017