MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-GUARD; SOL-GUARD1ML INSULIN SAFETY SYRINGE W/FIXED NEEDLE 29G*1/2''(U-100 INSULIN ONLY)

Model Number	200017SG
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that they after administering an injection to a patient, one of our staff members attempted to slide up the safety sleeve.During this process, the safety sleeve came off completely instead of locking into place, which resulted in a needlestick injury to the staff member's finger.
Additional Manufacturer Narrative
Based on the investigation, no manufacturing abnormalities were identified in the reviewed batch records or archived samples.All evaluated samples met the established quality and performance specifications during visual inspection, safety mechanism activation simulation, and connection strength testing.The reported condition, in which the safety sleeve detached during activation, could not be reproduced during the investigation.Additionally, our risk evaluation, conducted in accordance with iso 14971, indicates that the residual risk associated with this failure mode is low and no trends related to this issue have been identified during our track-and-trend analysis.

• Brand Name: SOL-GUARD
• Common Device Name: SOL-GUARD1ML INSULIN SAFETY SYRINGE W/FIXED NEEDLE 29G*1/2''(U-100 INSULIN ONLY)
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO.; no 658; gaochao road201803; shanghai, ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 24311808
• Report Number: 3014312726-2026-00011
• Device Sequence Number: 4941750
• Product Code: MEG
• UDI-Device Identifier: 00818392011821
• UDI-Public: (01)00818392011821(10)01504021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132681
• 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): 02/11/2026

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: 200017SG
• Device Lot Number: 01504021
• 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: 01/13/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2025
• 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