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-0013-01
Medical Device Problem Codes	Break (1069); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: customer reported: running nalaxone drip into primary tubing.End cracked.Patient harm/adverse reaction: no.Stopped active infusion: yes.Resulted in over/under infusion: no.Drug used: nalaxone.Steps taken: got new tubing.A preliminary review identified the following issue: administration set breaks (any part).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
One sample of ivenix administration set was returned for evaluation.No defects were observed during visual inspection.The gold foil corresponded to the specific code set-0013-25.A cracked rotating male luer lock connector was observed at the movil section of the mentioned component.The customer complaint is confirmed.The potential root cause could be related to a lack of compatibility of the luer lock with alcohol or another assembled component.The potential root cause could also be related to improper use by the customer where they exerted too much force on the assembly or applied too much alcohol to the connections causing breakage.An internal investigation was opened to determine the exact root cause.The current process controls detection include 1) post sterilization sampling final inspection, 2) 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, 3) sampling visual inspection is performed for rotating luer lock at incoming inspection area.

• 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: 21876304
• Report Number: 3014732157-2025-00396
• Device Sequence Number: 8741926
• Product Code: FPA
• UDI-Device Identifier: 00811505030054
• UDI-Public: 00811505030054
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/24/2025

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-0013-01
• Device Catalogue Number: SET-0013-01
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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