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

Catalog Number	67PFSS55
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: 2025 was the year of the event but there were various days of the event, and specific days were not reported.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 issue is that the pilot port was retracting into the pilot balloon when inflated with water.Device retrieved from the patient and supplied a new one.The patient has used it for 4 times.Patient is safe, device removed from the house.Datix to be done and tertiary hospital informed about the problem.Defective device removed from the patient and new one provided.The defect was found when the tube was in situ of the patient.Only 1 item was affected, which was used for 4 weeks only.It was found by parents and replaced it with a new tube.There was patient involvement and no patient harm/adverse vent reported.
Additional Manufacturer Narrative
D9 - date returned to mfg: 7-nov-2025.H3: one used sample and syringe were received for device analysis.Visual inspection was performed, and no physical damage or other anomalies were observed.Functional testing was performed where the trach was inflated with the 5ml syringe attached to the pilot balloon of the tube and slowly inflated with 5ml of sterile water.The cuff inflated with no evidence of the pilot port retracting into the pilot balloon.The customer¿s issue could not be confirmed.

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23511069
• Report Number: 3012307300-2025-12244
• Device Sequence Number: 9955001
• Product Code: JOH
• UDI-Device Identifier: 10351688518729
• UDI-Public: (01)10351688518729(17)280729(10)4418002
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: 67PFSS55
• Device Lot Number: 4418002
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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 Age: 8 YR
• Patient Sex: Female