MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V BIVONA FLEXTEND PLUS PEDIATRIC AND NEONATAL TRACH TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67PFSS30
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was stated that when they attempted to insert the trach into the patient, the cuff was tested prior to insertion and did not inflate with water or air.Everything introduced into the cuff, including the retention balloon at the top, flowed back into the syringe.As a result, the backup trach was used.When the backup trach was inserted, the patient experienced immediate distress, so it was removed.The patient¿s original trach was then reinserted.They were forced to use the backup trach because there was no additional tracheostomy tube available in the home.The patient was a 10-month-old tracheostomy patient on a ventilator, making it critical to have backup tracheostomy tube available in the home.There was reported patient involvement and no reported patient harm.

• Brand Name: BIVONA FLEXTEND PLUS PEDIATRIC AND NEONATAL TRACH TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; +1(224)706-2300
• MDR Report Key: 24925573
• Report Number: 3012307300-2026-03958
• Device Sequence Number: 14797703
• Product Code: JOH
• UDI-Device Identifier: 10351688518675
• UDI-Public: (01)10351688518675(17)290104(10)4445642
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2026

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: 67PFSS30
• Device Lot Number: 4445642
• Was Device Available for Evaluation?: No
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2024
• 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: 10 MO
• Patient Sex: Unknown