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

Model Number	16-N251S
Medical Device Problem Codes	Decoupling (1145); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the archive sample analysis.Based on the determined risk priority number, the residual risk related to the complaint is considered acceptable.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.Sol millennium continues to monitor this kind of issue.Additional assessment will be taken if a significant pattern emerges.Unconfirmed.
Event or Problem Description
Customer reported that the needle hub could not attach securely to the syringe, which resulted in the medication leaking out.
Additional Manufacturer Narrative
The defect could not be confirmed based on the returned sample analysis.This appears to be an isolated incident for this item and trending will be performed peridically to determine whether additional actions are needed.

• 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: 22790978
• Report Number: 3014312726-2025-00180
• Device Sequence Number: 20960217
• Product Code: FMI
• UDI-Device Identifier: 10612479244624
• UDI-Public: (01)10612479244624(10)CSOB01-01
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K123684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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
• Operator of Device: Health Professional
• Device Model Number: 16-N251S
• Device Lot Number: CSOB01-01
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2021
• 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