MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA. SOL-MILLENNIUM; SOL-CARE 3ML LUER LOCK SAFETY SYRINGE W/EXCH NEEDLE 23G*1''

Model Number	TW100077IMLD
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our evaluation indicates that the overall risk for the reported failure is low.However, sol millennium decided to open a supplier corrective action request to the supplier for further investigation of the issue.All actions will be followed in the scar number: (b)(4).Once the scar report is available a detailed corrective action will be shared.This report was initially submitted on 04/04/2025.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
Customer reported that when the vaccine is administered in the outpatient clinic, leakage begins to leak near the needle, resulting in a shortage of medicine and a new bottle of medicine is required.
Additional Manufacturer Narrative
This report when initially submitted encountered an internal issue potentially related to database connectivity.This issue was identified while implementing capa-57 which was opened following an fda inspection.This supplemental mdr is being submitted to correct "event date" provided in the initial mdr 3014312726-2025-00064.The previously reported event date 07 mar 2024 was incorrect.The correct event date is 18 oct 2024.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-CARE 3ML LUER LOCK SAFETY SYRINGE W/EXCH NEEDLE 23G*1''
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA.; 311 s wacker dr, suite 4100; chicago IL
• Manufacturer (Section G): ZHEJIANG LONGDE PHARMACEUTICAL CO., LTD.; no.501, shunfeng rd.; hangzhou, zhejiang 31110 6; CH 311106
• Manufacturer Contact: jarryd franklin ; 311 wacker dr, suite 4100; chicago, IL 60606
• MDR Report Key: 22035444
• Report Number: 3014312726-2025-00064
• Device Sequence Number: 8781386
• Product Code: MEG
• UDI-Device Identifier: 00818392015027
• UDI-Public: (01)00818392015027(10)04402053
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Consumer,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TW100077IMLD
• Device Lot Number: 04402053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 05/29/2025; 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• 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