MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-M 10ML LUER LOCK SYRINGE STERILE CONVENIENCE TRAY

Model Number	P180010TU
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported: we observed rust-like particles in one of the 10ml syringes from lot# 04301002.Please find the attached image and a small video.Please let us know the way forward to address this issue.
Additional Manufacturer Narrative
No anomalies were found on archived and received samples of sol-m 10ml luer lock syringe sterile convenience tray ref (b)(4), lot 04301002 checked.After investigation, based on photo, we can confirm the presence of particles on the rubber gasket due to a contamination compatible with the compression moulding of the rubber gasket.For this reason, the issue was investigated on the rubber gasket supplier which recognised the defect as an isolated production accident.To avoid this kind of defect corrective actions are: · installation of an automatic control system capable of discriminating the gasket surface and rejecting the defective part if necessary · complaint was shared with all involved personnel to improve their awareness regarding this issue.Sol-millennium will continue to monitor this type of issue and if data will increase, further evaluation will be performed.This report was initially submitted on 07/12/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Additional Manufacturer Narrative
This complaint was confirmed based on customer provided evidence.As a result, scar 20250301 was initiated at the manufacturing site to track the investigation and application of corrective actions associated with the event.Corrective actions include retrainining personel on proper cleanroom gown procedure and tray cleaning process, as well as establish work instructions for proper storage of materials.
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 10ML LUER LOCK SYRINGE STERILE CONVENIENCE TRAY
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr.,; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG LONGDE PHARMACEUTICAL CO., LTD.; no.510 shunfeng road; linping district hangzhou; zhejiang, 31110 6; CH 311106
• Manufacturer Contact: jarryd franklin ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 22035642
• Report Number: 3014312726-2024-00274
• Device Sequence Number: 15650506
• Product Code: FMF
• UDI-Device Identifier: 00810062434305
• UDI-Public: (01)00810062434305
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2025

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: P180010TU
• Device Lot Number: 04301002
• 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: 07/08/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 05/28/2025; 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• 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