MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA TUBES NEO/PED FLEXTEND PLUS; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67PFP50
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that a pediatric tracheostomy tube had an issue with two tubes splitting while in use with one of the pediatric patients.There was patient involvement but no patient harm.This event would cause in adequate ventilation to the patient when in use.
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• Brand Name: BIVONA TUBES NEO/PED FLEXTEND PLUS
• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25753064
• Report Number: 3012307300-2026-07242
• Device Sequence Number: 21444981
• Product Code: JOH
• UDI-Device Identifier: 10351688518514
• UDI-Public: (01)10351688518514(17)300324(10)6107646
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K923878
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2026

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: Other
• Device Catalogue Number: 67PFP50
• Device Lot Number: 6107646
• 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: 06/24/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 4 YR
• Patient Sex: Unknown