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

Model Number	67SP030
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
It was reported that the cuff component of the bivona tracheostomy tube failed to inflate.This product problem was observed during testing.There was no patient involvement.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10935937
• Report Number: 3012307300-2020-12018
• Device Sequence Number: 2322498
• Product Code: JOH
• UDI-Device Identifier: 15021312000696
• UDI-Public: 15021312000696
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2020

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 Expiration Date: 01/14/2025
• Device Model Number: 67SP030
• Device Catalogue Number: 67SP030
• Device Lot Number: 3931152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1