MAUDE Adverse Event Report: ICU MEDICAL MANUFACTURING S.A. DE C.V. BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67PFPS55
Medical Device Problem Codes	Gas/Air Leak (2946); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
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 reported that the parents of the patient informed the customer that an emergency tracheostomy change had to be performed due to the balloon failure on the child's tube.The tube has only been changed twice previously, on (b)(6) 2025 and (b)(6) 2025.The event occurred at the space centre for children with complex needs.The provided patient details are as follows: initials - msa, age - 10 years 7 months, gender - male, weight ¿ 39,4kgs and ethnicity/race ¿ british asian.There was patient involvement and no harm.A similar complaint from the customer has been documented under cn-364723.
Additional Manufacturer Narrative
Received one device.Visual inspection found no damage related to customer concern.A leak was observed at the junction of the inflation balloon and the tubing leading to the cuff immediately upon inflation.Confirmed customer complain of balloon failure probable cause, unintentional bending force during use.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL 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: 23604797
• Report Number: 3012307300-2025-12645
• Device Sequence Number: 9841233
• Product Code: JOH
• UDI-Device Identifier: 10351688518576
• UDI-Public: (01)10351688518576(17)281009(10)4434896
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: Health Professional
• Device Catalogue Number: 67PFPS55
• Device Lot Number: 4434896
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• 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