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-0032-01
Medical Device Problem Codes	Misassembled (1398); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: customer reported: "it was reported this week at our daily safety meeting that one of the primary sets (fk# set001325) came assembled with two female connectors instead of a male and a female.We do not have the packaging to track lot numbers.A preliminary review identified the following issue: misassembly - duplicate components.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
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.The customer complaint cannot be confirmed.Due to the absence of a sample and/or batch traceability information, it is not possible to confirm whether this issue originated from the manufacturing process.The possible root cause of a misassembly where the y-port was assembled in the rotating luer lock is likely associated with an operator error during the assembly process.As a preventive action, all personnel across shifts have been notified of the correct assembly procedures related to this type of defect.The current process controls detection include 1) sampling visual inspection pre-pouch sealing and final physical area, 2) 100% in-process visual inspection: performed during the manufacturing process, 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.

• 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: 24389887
• Report Number: 3014732157-2026-00216
• Device Sequence Number: 10208551
• 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): 03/27/2026

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-0032-01
• Device Catalogue Number: SET-0032-01
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown