MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-CARE 10ML LUER LOCK SAFETY SYRINGE W/EXCH NEEDLE 21G*1 1/2

Model Number	TW160072IMLD
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation in-progress.
Event or Problem Description
Customer complaint no.(b)(4).Customer reported that when drawing medicine with an empty needle, the medicine flowsbackward.Customer complaint no: (b)(4).Customer reported that after drawing the medication, leakage occurs from the black rubberstopper during injection.Customer complaint no: (b)(4).Customer reported that when drawing the medication, it leaks from the needle hub.Customer complaint no: (b)(4).Customer reported that the syringe malfunctioned, with leakage occurring from the back of therubber stopper.Customer complaint no: (b)(4).Customer reported that the back end of the syringe is leaking.Customer complaint no: (b)(4).Customer reported that the medication leaks out from the needle.
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the archive sample analysis.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.Sol millennium continues to monitor this kind of issue.Additional assessment will be taken if a significant pattern emerges.Unconfirmed.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-CARE 10ML LUER LOCK SAFETY SYRINGE W/EXCH NEEDLE 21G*1 1/2
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer Contact: mohanapriya kannupaiyan ; no. 501, shunfeng rd.,; linping district; 311106 hangzhou, zhejiang,, IL ; CH
• MDR Report Key: 22182335
• Report Number: 3014312726-2025-00088
• Device Sequence Number: 8505960
• Product Code: MEG
• UDI-Device Identifier: 00818392015041
• UDI-Public: (01)00818392015041(10)04311023,04402055
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092430
• 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): 07/09/2025

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: TW160072IMLD
• Device Lot Number: 04311023 ,04402055
• 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: 12/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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