MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. SOL-MILLENNIUM; SOL-M 1ML LUER LOCK SYRINGE W/O NEEDLE

Model Number	P180001PP
Medical Device Problem Codes	Crack (1135); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
"customer reported: we received a complaint from rivm for item p180001pp with batch 04105025.It had several defects: syringe without graduation marks: 1 piece.Syringe without plunger: 1 piece.Closed packaging without syringe: 1 piece.Syringe expanded and with fissures; fracture cracks: 3 pieces.".
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.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 04/08/2024.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.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M 1ML LUER LOCK SYRINGE W/O NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 311 south wacker drive; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG LONGDE PHARMACEUTICAL CO., LTD.; no. 501, shunfeng rd; linping district; zhejiang, hangzhou 31110 6; CH 311106
• Manufacturer Contact: jarryd ; 311 south wacker dr.; suite 4100; chicago 60606
• MDR Report Key: 22035476
• Report Number: 3014312726-2024-00192
• Device Sequence Number: 8781387
• Product Code: QNQ
• UDI-Device Identifier: 00818392018165
• UDI-Public: (01)00818392018165(17)260531(10)04105025
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K242291
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 05/31/2026
• Device Model Number: P180001PP
• Device Lot Number: 04105025
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2021
• 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