MAUDE Adverse Event Report: FRESENIUS KABI USA, LLC IVENIX, INC.; LVP BLOOD PRODUCTS ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, Y-SITE, MESH FIL

Model Number	SET-0014-1
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the execution of leak prevention test on (b)(6) 2025, during a fresenius kabi v&v plan, a sample from one of the conditioning group set-0014 experienced a leak on the primary port due to tubing bond separation.Microscopic evidence indicates insufficient solvent application and/or incomplete tube insertion during assembly resulting in a leak.The defect was determined to be most likely caused due to the manufacturing process and not related to the design change under test.This was identified on (b)(6) 2026.Additional information is needed to complete the investigation.

• Brand Name: IVENIX, INC.
• Common Device Name: LVP BLOOD PRODUCTS ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, Y-SITE, MESH FIL
• Manufacturer (Section D): FRESENIUS KABI USA, LLC; 50 high street; suite 50; north andover MA 01845
• Manufacturer (Section G): FRESENIUS KABI USA, LLC; 50 high street; suite 50; north andover MA 01845
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047
• MDR Report Key: 25037641
• Report Number: 3014732157-2026-02041
• Device Sequence Number: 9921070
• Product Code: FPA
• UDI-Device Identifier: 00811505030030
• UDI-Public: 00811505030030
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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 Model Number: SET-0014-1
• Device Catalogue Number: SET-0014-1
• Device Lot Number: 851-PRN-089548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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