MAUDE Adverse Event Report: ICU MEDICAL, INC BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	670190
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 information becomes available.
Event or Problem Description
It was reported that the cuff tore and leaked fluid.The cannula was in use for approximately four weeks and it was removed and cleaned about twice during that time.The issue occurred one hour after the cannula was inserted.A new cannula was inserted immediately.The incident occurred while in use with the patient, at an intensive care shared living community.The operator of the device at the time of the incident was a healthcare professional.There was no human harm or adverse event, and no medical intervention was needed.
Additional Manufacturer Narrative
G4 - pma/510(k) #: corrected.D3 - postal code, h3, h6: updated.The suspect product was returned for evaluation.Visual inspection confirmed that there were no anomalies found.Functional testing was performed and was found that there was a pinhole leak in cuff that occurred after inflation.Closer examination revealed that there was a tear on the trach cuff.The allegation made by the complainant was confirmed and the probable root cause was determined to be cuff damage.

• Brand Name: BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL, INC; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25129459
• Report Number: 3012307300-2026-04754
• Device Sequence Number: 13330163
• Product Code: JOH
• UDI-Device Identifier: 15021312006094
• UDI-Public: (01)15021312006094
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: UNKNOWN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: 670190
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 07/01/2026
• 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