MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-CARE; SOL-CARE 1ML INSULIN SAFETY SYRINGE W/FIXED NEEDLE 29G*1/2''

Model Number	100017IM
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
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.Sol millennium continues to monitor this kind of issue.Additional assessment will be taken if a significant pattern emerges.
Event or Problem Description
Customer reported syringes with leakage.The leakage appears in the syringe tip, between the inner part where the liquid is drawn and the outer section of the syringe.Customer description of quality issue: we filled nine syringes with hydroxocobalamin 5 mg/ml, removed the air, and adjusted the volume to 0.6 ml.The syringes were then packed in individual bags.Approximately 20 minutes later, during a routine check, leakage was discovered.

• Brand Name: SOL-CARE
• Common Device Name: SOL-CARE 1ML INSULIN SAFETY SYRINGE W/FIXED NEEDLE 29G*1/2''
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr.,; suite 4100; chicago IL 60606
• Manufacturer (Section G): SOL-KL (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED; xinpan road 189; xinqiao; songjiang, shanghai 20161 2; CH 201612
• Manufacturer Contact: intheran annadurai ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 23616551
• Report Number: 3014312726-2025-00209
• Device Sequence Number: 18384756
• Product Code: MEG
• UDI-Device Identifier: 00818392014907
• UDI-Public: (01)00818392014907(10)05211001
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K092413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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: 100017IM
• Device Lot Number: 05211001
• 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: 10/24/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2023
• 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