MAUDE Adverse Event Report: ICU MEDICAL, INC. BIVONA TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	XT25BS40NGF135N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
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 information becomes available.
Event or Problem Description
It was reported that the tube broke after use.The trach tube was replaced.There was patient involvement, no injury was reported.
Additional Manufacturer Narrative
H3: one used product was received for analysis.Visual inspection identified that a fixed connector had broken off of the connector portion embedded in the silicone and slight marks could be seen on the inside of the connector.No other damage is observed.There is evidence of an attachment being used and connected to the connector.Based on the geometry of the break, excessive force was used to pull the tracheostomy accessory apart from the connector, pulling the connector away from the device.Ifu 10018908-001 section 4.6 explains how to disconnect an accessory from the connector using the disconnecting wedge sent with all devices.The evidence shows the ifu was not followed.The defect is observed but was caused by user error; therefore, the complaint cannot be confirmed.

• Brand Name: BIVONA TRACHEOSTOMY TUBE
• 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 ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23510199
• Report Number: 3012307300-2025-12235
• Device Sequence Number: 13178304
• Product Code: JOH
• UDI-Device Identifier: 10887709148250
• UDI-Public: (01)10887709148250(17)300225(10)GC000878
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: User Facility
• Initial Reporter Occupation: Nurse
• 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: Lay User/Patient
• Device Catalogue Number: XT25BS40NGF135N
• Device Lot Number: GC000878
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• 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