MAUDE Adverse Event Report: ICU MEDICAL, INC. BIVONA CUSTOM 3.5 FLEXTEND TTS NS +1/EA; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	FT17AN35NGF945N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Neck Pain (2433)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
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 the cuff did not seem to inflate and stay inflated.This was the patient's first tracheotomy change, and this caused undue trauma and some bleeding due to insertion and immediate removal.
Additional Manufacturer Narrative
One used sample was received for evaluation for the complaint that the cuff did not seem to inflate and stay inflated.The device history file was reviewed.There were no discrepancies noted relevant to the indicated failure mode.No cosmetic or functional defects nor damage identified during initial inspection.The reported device issue could not be duplicated.Therefore, the complaint cannot be confirmed.
Additional Manufacturer Narrative
Updated: d3 - mfr establishment name.Additional information was received on 05-mar-2026.Based on additional information received, updating the report to reflect that a patient was harmed as a result of the event.Furthermore, the description of the harm has been updated to indicate that the patient experienced trauma and bleeding.

• Brand Name: BIVONA CUSTOM 3.5 FLEXTEND TTS NS +1/EA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 5700 w 23rd ave; gary, IN 46406 ; 2247062300
• MDR Report Key: 21638629
• Report Number: 1824231-2025-00016
• Device Sequence Number: 8425934
• Product Code: JOH
• UDI-Device Identifier: 15019517368932
• UDI-Public: (01)15019517368932(17)290301(10)GB017817
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2026

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 Catalogue Number: FT17AN35NGF945N
• Device Lot Number: GB017817
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 01/16/2026; 03/05/2026
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 01/22/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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 Age: 5 MO
• Patient Sex: Unknown