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 Codes	Material Discolored (1170); Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the medication changes color when in syringe.
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the return sample and 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.Unconfirmed.This report was initially submitted on 03/18/2025.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
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 all manufacturer contact office information and udi provided in the initial mdr [3014312726-2025-00059].The previously reported was incorrect.The correct manufacture contact information is below; (b)(6), qa engineer, sol-millennium medical inc, 311 s.Wacker dr., suite 4100, chicago, il 60606, united states, (b)(6).The correct product udi is: (b)(4).

• 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 Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22035726
• Report Number: 3014312726-2025-00059
• Device Sequence Number: 21016072
• Product Code: FMF
• UDI-Device Identifier: 00818392018172
• UDI-Public: (01)00818392018172(10)04312080,04312052
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: 08/30/2026
• Device Model Number: P180003
• Device Lot Number: 04312080, 04312052
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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