MAUDE Adverse Event Report: ICU Medical, Inc. Bivona Flextend Pediatric and Neonatal Tracheostomy Tubes; Tube tracheostomy and tube cuff

Catalog Number	XA23LS60ZSC081N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two adult expandable circuits exhibited a defect where the inner cuff of the tracheostomy tube inflated simultaneously when air was added to the outer cuff.This issue was identified after the devices were placed in the patient¿s airway.No adverse effects occurred, as the patient was continuously monitored.There were patient involvement and no patient harm.
Additional Manufacturer Narrative
B3: the issue occurred in (b)(6) of 2026.H4: manufacture date is not available based on the reported lot number.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.

• Brand Name: Bivona Flextend Pediatric and Neonatal Tracheostomy Tubes
• 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 north,; minneapolis, MN 55442 ; +1(224)706-2300
• MDR Report Key: 25304187
• Report Number: 3012307300-2026-05460
• Device Sequence Number: 9579740
• Product Code: JOH
• UDI-Device Identifier: 15019517369793
• UDI-Public: (01)15019517369793(17)301111(10)GC012665
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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: XA23LS60ZSC081N
• Device Lot Number: GC012665
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2025
• 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: Male
• Patient Weight: 37 LB