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

Catalog Number	75HA70
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 stated that the patient with a tracheostomy was called to the department to perform rest efrs.This examination requires removing the patient¿s tracheostomy cannula and replacing it with a long balloon cannula, identical to those used in the resuscitation unit to ventilate patients with a tracheostomy.During the examination, which took place without difficulty, the balloon which had been tested before the introduction of the cannula, could not be deflated, and the cannula could not be removed.Good tolerance of the episode: sensation of dyspnea but spo2 normal at 98 percent, no sign of respiratory distress.The patient received medical treatment.
Additional Manufacturer Narrative
Device evaluation: one device received for device analysis.Service history review identified the complaint was not related to a previous service of the device within the review period.Functional testing and visual inspection performed during analysis.The customer reported complaint could not be confirmed and the probable root cause is unable to be determined.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, ADULT HYPERFLEX
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23919042
• Report Number: 3012307300-2025-13897
• Device Sequence Number: 13085388
• Product Code: JOH
• UDI-Device Identifier: 15021312013849
• UDI-Public: (01)15021312013849(17)271201(10)4351158
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081440
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 75HA70
• Device Lot Number: 4351158
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2022
• 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 Age: 71 YR
• Patient Sex: Unknown
• Patient Weight: 87 KG