MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-M 3ML LUER LOCK SYRINGE W/O NEEDLE

Model Number	P180003
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
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.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.Sol millennium continues to monitor this kind of issue.Additional assessment will be taken if a significant pattern emerges.Unconfirmed.
Event or Problem Description
Customer reported that the barrel cracked down length of barrel so leaks.
Additional Manufacturer Narrative
Archived samples from the complained lot 05010026 ref (b)(4) were analyzed and no abnormalities were observed.Returned samples from the affected lot were inspected and all were found to be within established specifications.The assembly line is equipped with an in-line control system capable of detecting barrel cracks.The results of the performed tests did not confirm the reported defect and did not allow identification of a possible root cause.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M 3ML LUER LOCK SYRINGE W/O NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): SHANGAI KAILE; #25,waigangtown; jiadingqu; shanghai, ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22574108
• Report Number: 3014312726-2025-00169
• Device Sequence Number: 18562317
• Product Code: FMF
• UDI-Device Identifier: 00818392018172
• UDI-Public: (01)00818392018172(10)05010026
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: 10/25/2025
• Device Model Number: P180003
• Device Lot Number: 05010026
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2020
• 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