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	670160
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Increased Respiratory Rate (2486)
Date of Event	12/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient dependent on a ventilator and with a tracheostomy tube inserted approximately 3 days prior, presented with a sudden deterioration in respiratory function (respiratory distress) requiring higher pressures.On arrival, the rt assessed the tracheostomy cuff and noted it was completely deflated.Approximately 10¿12 ml of sterile water was instilled into the cuff.Within 10 seconds, the pilot balloon completely deflated, with measured cuff pressure of 0 cmh2o.Simultaneously, ventilator leak increased to 70 l per min, and exhaled tidal volumes decreased to approximately 50 ml per breath, compared to the previously expected 450 ml.A tracheostomy tube change was performed in the er.Following removal, the original tracheostomy tube was tested for integrity.Upon instillation of sterile water into the cuff, water was observed squirting from the cuff, confirming a cuff defect.Tachypnea, desaturation, marked increase in ventilatory pressures, significant ventilator leak, and a marked decrease in tidal volume, measured at approximately 50 ml compared to 450 ml.A new bivona tracheostomy tube was inserted.A chest x-ray and ct scan were performed.There was a patient injury, but no patient death.
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 reportable information becomes available.
Additional Manufacturer Narrative
D9 - date returned to mfg: 2/16/2026.D4 - primary udi number: updated.H3 and h6 codes - updated.One used device was returned for investigation.The device was visually inspected and there were no physical damage or other anomalies observed.During the functional testing, the cuff failed to inflate and a leak was observed immediately during filling.The complaint of cuff deflating can be confirmed.The probable cause is unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24278811
• Report Number: 3012307300-2026-01004
• Device Sequence Number: 21297677
• Product Code: JOH
• UDI-Device Identifier: 15021312006032
• UDI-Public: (01)15021312006032(17)300311(10)6099828
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 670160
• Device Lot Number: 6099828
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown