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

Model Number	SET-0013-1
Medical Device Problem Codes	Failure to Prime (1492); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: customer reported: "we have had an issue with several of our primary tubing kits in the past month.Several had cracks and one in which we could not find a crack on but could not get it to back prime.The priming issue was from lot#: fa25d01027, set 0013-1.A preliminary review identified the following issue: unable to prime air from tubing set.Unknown if an active infusion was stopped.Reporting as a conservative measure.No adverse effects were reported.Additional information is needed to complete the investigation.
Event or Problem Description
No sample or picture available for analysis.Without the proper sample or picture evaluation is not possible to determine the probable root cause of the reported failure.Customer complaint cannot be confirmed.The potential root causes of the priming issue could be related to, 1) excess glue in secondary port causing and obstruction, 2) small syringes used by the customer.Current process controls detections include, 1) 100% leak and occlusion test are 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.The batch record fa25d01027 was reviewed.No exceptions were generated that could classify as a possible root cause of this defect.The finished good lot has passed all sampling acceptance criteria for all tests performed including in-process testing and product testing.

• Brand Name: IVENIX, INC.
• Common Device Name: LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT
• 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 ; 8475502913
• MDR Report Key: 22955732
• Report Number: 3014732157-2025-00946
• Device Sequence Number: 8404608
• Product Code: FPA
• UDI-Device Identifier: 00811505030054
• UDI-Public: 00811505030054
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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
• Device Model Number: SET-0013-1
• Device Catalogue Number: SET-0013-1
• Device Lot Number: FA25D01027
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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