MAUDE Adverse Event Report: FENWAL INTERNATIONAL INC. IVENIX, INC.; LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT

Model Number	SET-0013-1
Medical Device Problem Codes	Leak/Splash (1354); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: alarm- tubing set problem a preliminary review of the device logs was not performed.The administration set was returned for evaluation.The sample was evaluated and underwent a detailed 6m investigation.Visual examination identified a leak pattern near the side cassette area.However, repeat functional testing and confirmation testing could not reproduce the reported leak condition.The manufacturing process, equipment parameters, materials, and methods were reviewed and found to be within validated specifications.Extended production data and process validation records confirmed that the cassette welding process remains stable and capable.Based on the evaluation, the reported leak condition and alarm is confirmed.The investigation identified evidence suggesting a potential localized inner cassette leak associated with overheated plastic during the ultrasonic welding process, therefore triggering the tubing set problem alarm.However, review of validated welding parameters, production records, and additional production runs demonstrated that the welding process was operating within established controls and that no systemic manufacturing issue was present.The reported condition is considered an isolated event.The current process controls detection includes 1) 100% leak and occlusion test is performed through the leak and occlusion test machine in order to capture units with any blockage or leak failure mode, 2) quality sampling for final physical testing, for performing a flow and underwater leak tests, 3) 100% visual inspection during the manufacturing process and final physical inspections.Reporting as a conservative measure due to the leak during evaluation.No adverse effects were reported.

• Brand Name: IVENIX, INC.
• Common Device Name: LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT
• Manufacturer (Section D): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal ; DR
• Manufacturer (Section G): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal ; DR
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047 ; 8475502300
• MDR Report Key: 25473907
• Report Number: 3014732157-2026-02863
• Device Sequence Number: 21420790
• Product Code: FPA
• UDI-Device Identifier: 00811505030054
• UDI-Public: 00811505030054
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K183311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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
• Device Model Number: SET-0013-1
• Device Catalogue Number: SET-0013-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (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