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

Catalog Number	SP25JN50NGZ098N
Medical Device Problem Code	Material Split, Cut or Torn (4008)
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
B3: unknown; no information has been provided to date.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 cuff was torn at the distal end.The event occurred while in use with the patient and a tracheostomy tube change had to be performed as an emergency.There was patient involvement but no patient harm.
Additional Manufacturer Narrative
One used unit was received for evaluation.A visual inspection noted that the airway line and the pilot balloon are no longer connected.Further inspection of the airway line revealed that the airway line was separated right below where the adhesive is applied to the balloon.A portion of the airway remained attached inside balloon.Functional testing was performed and the cuff inflated.Manufacturing review was performed and this device passed both leak tests; therefore, there were no tears present in the inflation line prior to packaging the device.The observed defect cannot be attributed to the manufacturing process and was likely caused due to improper device handling.

• Brand Name: BIVONA 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 ; 2247062300
• MDR Report Key: 24769636
• Report Number: 3012307300-2026-03236
• Device Sequence Number: 15769808
• Product Code: JOH
• UDI-Device Identifier: 10887709175317
• UDI-Public: (01)10887709175317(17)301020(10)GC011887
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: SP25JN50NGZ098N
• Device Lot Number: GC011887
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2025
• 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: Unknown