MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	670170
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
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.The device has not been returned to the manufacturer.
Event or Problem Description
The patient began to experience increased work of breathing due to a large leak, but once the new device was inserted, the patient's condition stabilized.No increase in oxygen or other maneuvers was needed.There was no patient injury.
Additional Manufacturer Narrative
Device was returned for investigation.It was reported that as received no physical damage or other anomalies observed.In attempts to replicate clinical use the syringe was attached to the pilot balloon each tube and slowly attempted to be inflated with 10ml of sterile water per packaging directions.A leak was observed at the cuff.Upon closer inspection a small tear was observed at the location of the leak.The complaint of leaking can be confirmed due to the damage (tear) observed on the cuff.The probable cause of the damage is unknown.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: BIVONA TIGHT TO SHAFT TRACHEOSTOMY 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24465465
• Report Number: 3012307300-2026-01782
• Device Sequence Number: 16017870
• Product Code: JOH
• UDI-Device Identifier: 15021312006056
• UDI-Public: (01)15021312006056
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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: 670170
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 05/11/2026
• 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