MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA TRACHEOSTOMY TUBE, ADULT HYPERFLEX; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	75HA80
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that in the operating room (or), while placing the tube and inflating the cuff on the patient, the cuff appeared to be adhered and could not be inflated.Air abnormally remained in the pilot balloon and had difficulty entering the cuff, and resistance was observed.There was patient involvement and there was unknown patient harm.
Additional Manufacturer Narrative
H3/h6: investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
One unit was received for evaluation in used condition.Visual inspection confirmed the device had been used.Visual inspection did not identify any manufacturing defects with the device.Functional testing was performed and no anomalies were identified.The investigation did not find a manufacturing defect with the returned device.The instructions for use state under warnings, "failure to align the shaft graduation marks between the arrows marked on the neck flange locking ring may result in occlusion of the inflation lumen causing restriction to inflation and deflation of the cuff.The inflation lumen in the shaft must not be clamped by the flange locking ring." under set-up the instructions also state, "adjust the tube to the desired length.Align the shaft graduation marks with the arrows mark on the adjustable neck flange locking ring ensuring that the inflation lumen in the shaft lies in the cut-out section of the locking ring." the investigation determined that the instructions for use were not followed.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, ADULT HYPERFLEX
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no..4, parque; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24586490
• Report Number: 3012307300-2026-02353
• Device Sequence Number: 5573485
• Product Code: JOH
• UDI-Device Identifier: 15021312013856
• UDI-Public: (01)15021312013856(17)300219(10)6092472
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: 75HA80
• Device Lot Number: 6092472
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2025
• 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