MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-M; SOL-M 10ML LUER LOCK SYRINGE W/O NEEDLE

Model Number	P180010BS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our evaluation of the risk, which follows guidance from iso 14971, indicates that the overall risk for the reported failure is low.This evaluation is based on our track and trend analysis and risk management files which are evaluated and updated constantly based on post market surveillance.As we performed multiple follow-ups to retrieve the samples and lot/batch number but information not available.Due to this reason, we are not able to perform customer sample analysis and archived sample analysis.As part of our continued commitment to our customers, sol millennium will continue to monitor the complaints trend for the reported failure mode and take any corrective action based on our procedures, if a significant pattern emerges.
Event or Problem Description
Customer reported syringe in pack found to be cracked upon opening spt.

• Brand Name: SOL-M
• Common Device Name: SOL-M 10ML LUER LOCK SYRINGE W/O NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr.,; suite 4100; chicago IL 60606
• Manufacturer Contact: intheran annadurai ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 23423627
• Report Number: 3014312726-2025-00205
• Device Sequence Number: 8179451
• Product Code: FMF
• UDI-Device Identifier: 00810018095161
• UDI-Public: (01)00810018095161
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K101359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2025

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: P180010BS
• Device Lot Number: UNKNOWN
• 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: 10/07/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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