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

Catalog Number	670175
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when doing inflation during pre-test the water abnormally remained in the pilot balloon and had difficulty entering the cuff, and resistance was observed.The same problem seemed to occur during deflation.Additionally, it seemed to be uneven inflation on both sides of cuff.The device is available for investigation.Event occurred during pre-test in taiwan.There were no patient harm or adverse events reported as a result of the event.
Additional Manufacturer Narrative
One device was returned for analysis of complaint of inflation and deflation issues.Investigation found deflation rates were observed to be within acceptable ranges, and no additional resistance was noticed during inflation.Asymmetrical inflation was observed.No visible damage or imperfections were identified.Device met acceptance criteria for leak testing asymmetrical inflation.No defects were identified and reported complaint issue could not be reproduced.The defect could not be confirmed or attributed to the manufacturing process.No further action is planned at this time.This file was originally incorrectly filed under registration number mrn (b)(6).The date of that submission was 8-mar-2025.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, ADULT
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24240279
• Report Number: 3012307300-2026-00792
• Device Sequence Number: 9184088
• Product Code: JOH
• UDI-Device Identifier: 15021312006063
• UDI-Public: (01)15021312006063(17)280111(10)4366563
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: 670175
• Device Lot Number: 4366563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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