MAUDE Adverse Event Report: ICU MEDICAL, INC. BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60PFP45
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
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 information becomes available.
Event or Problem Description
It was reported that the trach tube exhibited a leakage at the outer connection.There was patient involvement, no injury was reported.
Additional Manufacturer Narrative
A total of four pictures were returned.Three images showed the tracheostomy tube: one showed packaging information.The complaint of leakage at the outer connection cannot be confirmed based on the returned images.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.

• Brand Name: BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23310737
• Report Number: 3012307300-2025-11488
• Device Sequence Number: 4967593
• Product Code: JOH
• UDI-Device Identifier: 15021312005813
• UDI-Public: (01)15021312005813(17)290616(10)6017609
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: Lay User/Patient
• Device Catalogue Number: 60PFP45
• Device Lot Number: 6017609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2024
• 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