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 the tracheostomy tube experienced unintended inflation of the inner cuff when air was introduced into the outer cuff, which prevented the patient from speaking.The issue was identified after the device had been placed in the patient's airway.There was patient involvement associated with this event; however, no patient harm or adverse effects were reported, as the patient remained under continuous monitoring.
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number (b)(4).The date of that submission was 27-may-2026.One sample was returned for evaluation.A review of the lot history identified no nonconformities that could have contributed to the reported complaint.Visual inspection and functional testing were performed, and no anomalies were observed.The reported issue could not be replicated, as inflation or deflation of one cuff did not influence the other cuff during testing.Therefore, the complaint was not confirmed.

• 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 ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50916124
• Report Number: 1824231-2026-00010
• Device Sequence Number: 5778092
• Product Code: JOH
• UDI-Device Identifier: 15019517369793
• 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
• 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: Other
• Device Catalogue Number: XA23LS60ZSC081N
• Device Lot Number: GC012665
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial 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