MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-CARE; SOL-CARE 3ML LUER LOCK SYRINGE W/SAFETY NEEDLE 25G*1

Model Number	32510SN
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that while drawing up vaccine using a sol-care syringe with safety needle, the vaccine started spraying out of the needle at the hub, so was unable to draw up full dose of vaccine.
Additional Manufacturer Narrative
Investigation in progress.No samples are available of the suspect device.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
No samples or pictures of the impacted sol-care 3ml luer lock syringe with safety needle 25g×1, ref 32510sn, lot 04011001, were received; therefore, the reported issue could not be verified.Based on the batch record review and risk assessment, no abnormalities or deviations were identified.The manufacturing process and raw materials were confirmed to be within specifications.Lot 04011001 expired on 31 october 2025; therefore, archive sample analysis was not performed.Our evaluation of the risk, which follows guidance from iso (b)(4), indicates that the residual risk of the reported failure is low.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.

• Brand Name: SOL-CARE
• Common Device Name: SOL-CARE 3ML LUER LOCK SYRINGE W/SAFETY NEEDLE 25G*1
• 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: 23496482
• Report Number: 3014312726-2025-00220
• Device Sequence Number: 8992928
• Product Code: FMI
• UDI-Device Identifier: 00818392019063
• UDI-Public: (01)00818392019063(10)04011001
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K241821
• 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): 12/15/2025

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 Expiration Date: 10/31/2025
• Device Model Number: 32510SN
• Device Lot Number: 04011001
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• 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