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

Catalog Number	67HA70
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after four hours replacing the device, the residual amount of water in the cuff was 1ml.This problem was resolved by replacing with another brand pvc tracheostomy tube.There was no medical intervention required.There was unknown patient harm or adverse event reported as a result of the event.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H6: codes were updated.One device was returned for investigation.The defect is observed but cannot be attributed to the manufacturing process.Based on the contaminant and amount of biological build up on the device, it can be surmised that the device was in use far longer than recommended per ifu0000839 section 2.0 as a temporary device.The age of the device at the time of submission suggests this device was used beyond its lifespan, as well.Additionally, the cut reported with clean lines and sharp angles were caused during use and not during the manufacturing process.The probable cause of the reported problem unknown.

• Brand Name: BIVONA TTS ADJUSTABLE FLANGE HYPERFLEX TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21778499
• Report Number: 3012307300-2025-03832
• Device Sequence Number: 15420895
• Product Code: JOH
• UDI-Device Identifier: 15021312013801
• UDI-Public: (01)15021312013801(17)271014(10)4327363
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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 Catalogue Number: 67HA70
• Device Lot Number: 4327363
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown