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

Catalog Number	75FHXL60
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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 the patient had an existing tracheostomy tube that was requiring very high cuff pressures to seal.The same tube was obtained to replace the tracheostomy tube.When the pilot balloon was inflated to check the function, it was noted that the balloon did not inflate equally, one side was significantly more filled with air than the other.Decision not to place this tube in the patient.The original intended procedure was tracheostomy tube change.The tracheostomy in the patient seems to require very high pressures to seal.It is the same size and brand of trach, but we do not have its original lot number or information.The defective item was never placed in the patient.The event occurred at the hospital in the patient's room.The outcome of the event was that the patient had an existing problematic cuff on their trach (required high pressures) that was repositioned and left in at the time.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D9: date returned to mfg.: 12/10/2024.D3 - mfg establishment name, h3 and h6.Codes: updated.Device evaluation: received for investigation one (1) used product sample.The device met all visual and testing requirements related to the reported complaint defect.No defect was identified, and the tracheostomy cuff inflates symmetrically visibly and when measured.The defect cannot be confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: BIVONA FIXED FLANGE HYPERFLEX CUFFED TRACHEOSTOMY TUBE
• 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: 21036250
• Report Number: 1824231-2024-00105
• Device Sequence Number: 7573424
• Product Code: JOH
• UDI-Device Identifier: 15021312015676
• UDI-Public: (01)15021312015676(17)260624(10)4156730
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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 Expiration Date: 06/24/2026
• Device Catalogue Number: 75FHXL60
• Device Lot Number: 4156730
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2021
• 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: 65 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG