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

Catalog Number	ZT25LN25NGE261N
Medical Device Problem Codes	Difficult to Insert (1316); Suction Failure (4039)
Health Effect - Clinical Code	Hyperextension (4523)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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 device did not allow the 8fr suction catheter to pass smoothly without some resistance.While the device was in use on a patient, the tube had already been inserted, and the issue was not noticed until after placement when suction was initiated to clear secretions.The suction catheter could not be inserted properly.The bedside team was able to replace the tube with the patient¿s original trach, but this resulted in an unplanned trach change.Medication intervention was required because the patient had to be switched back to the original trach, as the custom tubes were not patent enough for 8 fr suction catheters.The issue was eventually resolved, but it took a third set of tubes to obtain ones that were patent.The patient had to remain strapped down with the neck hyperextended while waiting for the custom tubes, and because the tubes were not patent, the patient stayed in that position until the third set arrived and was confirmed usable.The patient¿s date of birth was (b)(6) 2025; the patient was 4 months old during the event, weighed 5.74 kg, and was of non-hispanic/other race.There was no reported patient harm.
Additional Manufacturer Narrative
D9: date returned to mfg.: 13-feb-2026.D4 - lot # and h4 - device mfr date: additional information.H6.Codes: updated.Device evaluation: received part number zt25ln25nge261 lot gc0015415 in a sealed tray.The tray was opened and the device was visually inspected, and no issues were identified with the device.Custom devices use extruded shafts that are d-shaped to contain the embedded lumen.Part of the process is to bevel the id so that d portion of the shaft transitions with the connector while not removing too much material so that the wall is compromised and creates a leak.Evidence of this step was visible on the device.Manufacturing tolerances of the extruded shaft create variation in the connector to shaft transition.There were no issues detected with the transition.A 6 fr portex catheter did not catch when passing through the connector and it smoothly traveled through the device in its free state.The instruction for use states that prior to insertion of the tracheostomy tube, ensure that the suction catheters to be used for tracheal toilet can be easily passed through the tube bore.The complaint was not confirmed.A 6fr catheter smoothly traveled through the tube in its free state.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL, INC..; 5700 west 23rd avenue,; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24630692
• Report Number: 3012307300-2026-02670
• Device Sequence Number: 18388805
• Product Code: JOH
• UDI-Device Identifier: 10887709182049
• UDI-Public: (01)10887709182049
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: ZT25LN25NGE261N
• Device Lot Number: GC015415
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2026
• 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: 4 MO
• Patient Sex: Unknown
• Patient Weight: 6 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White