MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	67PFSS35
Medical Device Problem Code	Inflation Problem (1310)
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
H3: no product was received for analysis.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Without the return of the product a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
Additional Manufacturer Narrative
D9: date returned to mfg.: 11/13/2025.H3 and h6.Codes: updated.Device evaluation: received one (1) used product sample.As received no damage or anomalies were observed.A syringe was attached to the pilot balloon of the tube and slowly inflated with 5ml of sterile water per packaging directions.The cuff of the set was observed not to inflate.The cuff was gently pinched off the inflation line to allow fluid into the cuff and the cuff inflated.The complaint of the trach not inflating can be confirmed.Corrective actions are in process including root cause analysis.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.
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 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 balloon failed to inflate.Patient involvement was noted; however, it is unclear whether the event occurred during pre-use testing or during actual patient use.

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 23532369
• Report Number: 3012307300-2025-12369
• Device Sequence Number: 10187021
• Product Code: JOH
• UDI-Device Identifier: 10351688518682
• UDI-Public: (01)10351688518682(17)290402(10)4466228
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2026

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: 67PFSS35
• Device Lot Number: 4466228
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 11/25/2025; 01/28/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/10/2025; 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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