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

Catalog Number	AT26BS40NSA197N
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information has been provided to date.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 reported that the trach was only used in the patient for approximately 6 hours before a leak was noticed.It was tested prior to insertion and appeared to be fine.The cuff had been inflated with 2.0-3.0cc of water to achieve a proper seal, and after the leak was noted, the trach was removed and it was confirmed that the tts cuff was broken/faulty and leaked water when inflated.There were patient involvement and no patient harm.
Additional Manufacturer Narrative
D4 - primary udi number, h3, h6: updated.The suspect product was returned for evaluation.Visual inspection confirmed that there were no anomalies found.Leak test was performed by inflating the cuff with water using a syringe and it was confirmed that a leakage was observed.Upon closer inspection, a tear was observed on the cuff's surface.The allegation made by the complainant was confirmed.The probable root cause of the event was due to the cuff damage.

• Brand Name: BIVONA TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24691044
• Report Number: 3012307300-2026-02928
• Device Sequence Number: 13174963
• Product Code: JOH
• UDI-Device Identifier: 10887709186405
• UDI-Public: (01)10887709186405
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

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: AT26BS40NSA197N
• Device Lot Number: GC017881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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