MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-M; SOL-M 5ML LUER LOCK SYRINGE W/EXCH NEEDLE TRAY 21G*1'' (SEALED CAP)

Model Number	1852110T
Medical Device Problem Code	Decoupling (1145)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation, no abnormalities were identified during the batch record review, visual inspection, or dimensional and mechanical testing conducted on the archived samples in compliance with iso 80369-7:2021.All test results met the applicable specifications, confirming that the product complied with the established quality and manufacturing standards.The reported issue of detached or loose needles could not be reproduced under standard testing conditions.As the defective samples were not available for evaluation, it was not possible to determine the exact root cause of the issue.Should defective samples become available in the future, a detailed investigation will be carried out accordingly.Our risk evaluation, conducted in accordance with iso 14971, indicates that the residual risk associated with this failure mode is low.No trends related to this issue have been identified during our track-and-trend analysis.
Event or Problem Description
Customer reported that the 3cc and 5cc are both arriving with barely any needles attached, and the ones that are attached will get stuck in the vial after drawing the dose and the syringe will be in hand.

• Brand Name: SOL-M
• Common Device Name: SOL-M 5ML LUER LOCK SYRINGE W/EXCH NEEDLE TRAY 21G*1'' (SEALED CAP)
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG LONGDE PHARMACEUTICAL CO., LTD; no. 501, shunfeng rd.,; linping district; 311106 hangzhou, zhejiang, ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 23921449
• Report Number: 3014312726-2025-00213
• Device Sequence Number: 9064295
• Product Code: FMF
• UDI-Device Identifier: 00818392013696
• UDI-Public: (01)00818392013696(10)04312019
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K241821
• 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): 12/30/2025

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: 1852110T
• Device Lot Number: 04312019
• 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: 12/05/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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