MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA. SOL-MILLENNIUM; SOL-M 5ML LUER LOCK SYRINGE W/O NEEDLE (BULK, STERILE)

Model Number	P180005BS
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No anomalies were found when checking archived and received samples of sol-m 5ml luer lock syringe w/o needle (bulk, sterile) ref: p180005bs, lot: 04402066.Picture received from the customer for evaluation confirmed the complained issue, damaged-gasket.The manufacturing partner suspects the complained defect could have been caused by an isolated and occasional debugging of the gasket's enter track automatic assembly machine, in this case a second gasket remained accidentally stuck to the other, plunger was directly assembled with the barrel.The inspectors did not find the defective product in time resulting in the complained piece being placed on the market.As a corrective action, the manufacturing partner informed all related workers about the complaint received and arranged training focusing on the customer-complained defect.The issue is considered an accidental and isolated case.Sol millennium will continue to monitor this kind of issue and in case the number of complaints increases, further evaluation and corrective actions will be taken.This report was initially submitted on 11/26/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
"customer reported: i would like to inform you that during our process we have found damaged gasket in the syringe.".
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 "report type, investigation finding (c) code, investigation conclusion (d) code" provided in the initial mdr 3014312726-2024-00359.The previously reported report type is adverse event and product problem was incorrect and investigation finding (c): 213, investigation conclusion (d): 4323 were also incorrect.The correct report type is product problem only and correct codes were investigation finding (c): 170, investigation conclusion (d): 25.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M 5ML LUER LOCK SYRINGE W/O NEEDLE (BULK, STERILE)
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA.; 311 s wacker dr, suite 4100; chicago IL
• Manufacturer (Section G): ZHEJIANG LONGDE PHARMACEUTICAL CO., LTD.; no.501, shunfeng rd.; hangzhou, zhejiang 31110 6; CH 311106
• Manufacturer Contact: jarryd franklin ; 311 wacker dr, suite 4100; chicago, IL 60606
• MDR Report Key: 22035457
• Report Number: 3014312726-2024-00359
• Device Sequence Number: 15617243
• Product Code: FMF
• UDI-Device Identifier: 00810018095147
• UDI-Public: (01)00810018095147(17)290228(10)04402066
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Consumer,Distributor
• Initial Reporter Occupation: Other
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P180005BS
• Device Lot Number: 04402066
• 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: 09/30/2024
• 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): Yes
• Date Device Manufactured: 07/05/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown