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

Model Number	65SN035
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device cuff would not inflate.No adverse effects reported.
Additional Manufacturer Narrative
Investigation completed on a smiths tracheostomy|silicone - bivona tubes neo/ped aire-cuff.Two pictures were received.In first picture, we observed one (1) label from p/n 533640 l/n 3988353 and p/n 65sn035, l/n 3721073.Engineering process and testing reviewed.No root cause could be determinate since no samples were received to perform inspection or testing and per picture received the defect is unclear.No corrective actions were taken since the complaint was not confirmed as leak was not verified.
Event or Problem Description
The cuff did not inflate.See product label photo attached.Summary of investigation results completed in h 10.Additional information on lot expiration and implementation.

• 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: 10795694
• Report Number: 3012307300-2020-11028
• Device Sequence Number: 2917687
• Product Code: JOH
• UDI-Device Identifier: 15021312000061
• UDI-Public: 15021312000061
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• 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,Followup
• Report Date (Section B): 12/07/2020

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 Expiration Date: 10/31/2023
• Device Model Number: 65SN035
• Device Catalogue Number: 65SN035
• Device Lot Number: 3721073
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1