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 Codes	Partial Blockage (1065); Deflation Problem (1149)
Health Effect - Clinical Codes	Hypoxia (1918); Increased Respiratory Rate (2486)
Date of Event	03/04/2026
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 reportable information becomes available.
Event or Problem Description
It was reported that a patient who underwent a tracheostomy in (b)(6) 2026 following a cervical-mediastinal cellulitis experienced difficulties during ventilator weaning.The tracheostomy cannula currently in place was inserted on (b)(6) 2026 (date deduced but not certain).After an hour and a half ventilation episode, the patient was placed on high-concentration oxygen therapy with the cuff deflated.The patient was then reconnected to mechanical ventilation using an astral 150 ventilator with the cuff inflated with 8 ml of sterile water (ppi).At 16:00, the patient presented a decrease in tidal volume, an increase in respiratory rate, and sweating.Tracheobronchial suctioning could not be properly performed because the suction catheter could not advance beyond 15 cm from the tracheal opening.An aerosol treatment was performed, after which significant leaks appeared on the astral 150 ventilator.The ventilator was therefore replaced with another model (dräger).Clinical consequences: the patient experienced oxygen desaturation requiring an urgent bronchoscopy performed under sedation and vasopressor support.The physician observed a progressive reduction of the cannula lumen as the cuff was inflated.The cannula was replaced with another cannula of the same diameter (6.0 mm), allowing a return to adequate ventilation parameters (tidal volume smaller than 300 ml, respiratory rate bigger than 30) on the astral ventilator and enabling tracheobronchial suctioning to be performed.
Additional Manufacturer Narrative
D3: updated.D9 - date returned to mfr: 16-apr-2026.G4: updated.H3 and h6 codes: updated.One suspect device was received for investigation.Visual inspection revealed no anomalies.Functional testing confirmed that the cuff inflated properly without any fluid loss, and no leaks were detected.The reported issue could not be verified, and the root cause could not be determined.

• 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: 24790159
• Report Number: 3012307300-2026-03311
• Device Sequence Number: 9844791
• Product Code: JOH
• UDI-Device Identifier: 15021312006032
• UDI-Public: (01)15021312006032
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: 670160
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 06/30/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VASOPRESSOR
• Patient Age: 58 YR
• Patient Sex: Female