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

Catalog Number	60A170
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
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 during set-up the opening was too small, so it was not possible to connect the speaking valve to the opening of the tracheostomy cannula.In other words, the speaking valve was loose and didn¿t fit properly.There was no patient involvement and no human harm.The event occurred when it was time for the patient to change the cannula, the product was unpacked and after the change, the speech valve was loose and fell at the slightest movement.After the incident, a new product was unpacked, and it worked perfectly.The speech valve sat very well.The patient was able to go home.The reporter stated that exactly the same problem happened on a previous occasion with the same patient, the problem was solved in the same way.
Additional Manufacturer Narrative
D3 - mfg establishment name, h3 and h6.Codes: updated.Device evaluation: received for investigation one used tracheostomy product.No damage was identified during visual inspection.Reported nonconformance was related to the dimensions of the connector.The part was measured and met specification the reported defect could not be replicated/confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: BIVONA TRACHEOSTOMY TUBES, ADULT UNCUFFED
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20666216
• Report Number: 1824231-2024-00094
• Device Sequence Number: 8231281
• Product Code: JOH
• UDI-Device Identifier: 15021312005561
• UDI-Public: (01)15021312005561(17)281023(10)4436118
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• 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 Catalogue Number: 60A170
• Device Lot Number: 4436118
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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