MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE, CUSTOM; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	FT21KN40NSE076N
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had to undergo an emergency trach change due to the pilot balloon leaking.Additional information was requested; however, no further specific details on this incident were received.No additional adverse affects to the patient, after the completion of the trach change, were reported.
Additional Manufacturer Narrative
Device lot number is unknown, no product information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updates not required.H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.A dhr review was not conducted since no lot number was provided.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, CUSTOM
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15339897
• Report Number: 3012307300-2022-17353
• Device Sequence Number: 6937491
• Product Code: JOH
• UDI-Device Identifier: 15019517287431
• UDI-Public: 15019517287431
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• 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): 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FT21KN40NSE076N
• Device Catalogue Number: FT21KN40NSE076N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown