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

Model Number	P180010BS
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported: the customer reports that on (b)(6) 2024, in the plastic surgery block, using syringes of 10ml luer, the syringe 10ml l/l 3 parts conc.Was find defected.Indeed, some grease in the plunger of the syringe was found and a black rubber remained in the body of the syringe.Observed fat in the piston of the syringe as well as the presence of rubber in the body of another syringe.
Additional Manufacturer Narrative
This report was initially submitted on 10/30/2024.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 report is being submitted to clarify that mdr 3014312726-2024-00344 was inadvertently submitted as a duplicate of mdr 3014312726-2024-00340.Both reports describe the same event.No new, additional, or updated information is available.This supplemental submission is provided solely to document that mdr 3014312726-2024-00344 was a duplicate entry.

• Brand Name: SOL-MILLENNIUM
• 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: jarryd franklin ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 22035715
• Report Number: 3014312726-2024-00344
• Device Sequence Number: 8733646
• Product Code: FMF
• UDI-Device Identifier: 00810018095161
• UDI-Public: (01)00810018095161
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K101359
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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?: 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: 10/21/2024
• 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): 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