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

Model Number	67P035
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device cuff would not inflate.No patient involvement.
Additional Manufacturer Narrative
Other, other text: h10 ? device evaluation results: the affected bivona tracheostomy tube was returned for investigation in used condition.The customer reported product problem (inflation failure) was not confirmed during functional testing.The cuff inflated as intended.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.No fault was found with the device.

• Brand Name: BIVONA PEDIATRIC TRACHEOSTOMY TUBE
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11167297
• Report Number: 3012307300-2021-00394
• Device Sequence Number: 19762485
• Product Code: JOH
• UDI-Device Identifier: 15021312006261
• UDI-Public: 15021312006261
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: Health Professional
• Device Expiration Date: 12/02/2024
• Device Model Number: 67P035
• Device Catalogue Number: 67P035
• Device Lot Number: 3907998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 02/07/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1