MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC MCKESSON; NEEDLE, SAFETY 25GX1" (HINGED STYLE)

Model Number	16-N251S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the item leaks where needle connects.No injury occurred.Medication was a vaccine.
Additional Manufacturer Narrative
Based on comprehensive investigation, including batch record review, archive sample analysis, customer sample evaluation, and risk assessment, no abnormalities were identified in the affected lot (csoe05-01).All tested samples met the applicable product specifications and requirements, including iso 80369-7:2021 standards.The reported issue of needle hub leakage could not be reproduced during simulated clinical use.There is no evidence to indicate a manufacturing defect.As no defective sample was received for evaluation, the root cause could not be determined.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.Based on the determined risk priority number, the residual risk related to the complaint is considered acceptable.

• Brand Name: MCKESSON
• Common Device Name: NEEDLE, SAFETY 25GX1" (HINGED STYLE)
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.; no. 758, 5th binhai road; binhai industrial park; longwan ,wenzhou,, zhejiang province ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 24838702
• Report Number: 3014312726-2026-00023
• Device Sequence Number: 9555851
• Product Code: FMI
• UDI-Device Identifier: 10612479244624
• UDI-Public: (01)10612479244624(10)CSOE05-01
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

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: Health Professional
• Device Model Number: 16-N251S
• Device Lot Number: CSOE05-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2025
• 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