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	Leak/Splash (1354); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: nurse reported: "report was received from our newport news office that they have had multiple primary sets from lot # fa25f16046 where "the secondary port on the cassette is coming off when either removing the syringe or a secondary tubing." no patient or staff injuries because of any of the failures.A preliminary review identified the following issue: administration set breaks (any part) an active infusion was not stopped.Reporting as a conservative measure.No adverse effects were reported.Additional information is needed to complete the investigation.
Event or Problem Description
One sample of ivenix administration set was returned for evaluation.The gold foil corresponded to set-0013-25.During the visual inspection it was identified a missing luer activated valve (secondary port) in the administration cassette.The separated k-zero was not returned for evaluation.Under microscope a residual glue was detected around the secondary port at the administration cassette.The customer complaint is confirmed.The most probable root cause of the reported incident is associated with a manufacturing assembly error related to the lack of uv glue application or insufficient curing time during the bonding process.This resulted in poor adhesion, causing the luer connector from the secondary port to become loose, detached, or missing, due to an improper joining operation performed by the operator.The current process controls detection include 1) post sterilization sampling final inspection, 2) 100% visual inspection related to separated components during the manufacturing process and final physical inspections, 3) the first piece inspection will be performed to the first final assembled kit manufactured per shift.This kit will be submitted to visual inspection as per the classification of defects included in this specification and as per the applicable drawing.The batch records fa25f16046 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
• MDR Report Key: 24789275
• Report Number: 3014732157-2026-00348
• Device Sequence Number: 10012399
• Product Code: FPA
• UDI-Device Identifier: 00811505030054
• UDI-Public: 00811505030054
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 05/19/2026

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?: No
• Device Model Number: SET-0013-1
• Device Catalogue Number: SET-0013-1
• Device Lot Number: FA25F16046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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