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

Catalog Number	67HA80
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
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.
Event or Problem Description
It was reported that after 5 hours set up, the residual amount of water in the cuff was 1ml.After 3 hours upon replacing the device, the residual amount of water in the cuff was 1ml.There was no medical intervention required.There was unknown patient harm or adverse events reported as a result of the event.
Additional Manufacturer Narrative
D9 - date returned to mfg: 11-aprl-2025.H3: three used products were returned for evaluation.Visual inspection found that one of the devices appeared not to be decontaminated and was covered in biological products including dried blood mixed with other biological contaminants.The tube was significantly discolored and there was a hole in the cuff.The other two devices did not have any leaks.Based on the contaminant and amount of biological build up on the device that leaked, 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.The defect is observed but cannot be attributed to the manufacturing process.

• 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: 21780405
• Report Number: 3012307300-2025-03850
• Device Sequence Number: 8636181
• Product Code: JOH
• UDI-Device Identifier: 15021312013818
• UDI-Public: (01)15021312013818(17)271108(10)4346852
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/06/2026

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: 67HA80
• Device Lot Number: 4346852
• 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: 01/27/2026
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• 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