MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-M; 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	05/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that during the 100% visual inspection process, several units were rejected for "particulate/material in the other category, suspended in solution or adhered to internal surface of container".This impacted four compounded lots.The particulate(s) were analyzed by the qc lab and determined to be a polyester fiber/natural fiber.
Additional Manufacturer Narrative
Based on the investigation performed, no abnormalities were identified in the batch manufacturing records or in the retained samples.The most probable contributing factors are associated with environmental and handling conditions, including the potential release of fibers and their adhesion to product surfaces.In addition, considering that the syringes are supplied sterile and empty, and that the reported contamination was identified in filled syringes, the exact stage at which the particulate matter was introduced cannot be determined with certainty.Both manufacturing-related and post-manufacturing handling conditions have been considered in the evaluation.As such, a definitive root cause could not be established, and it cannot be concluded whether the observed material originated during manufacturing or was introduced during subsequent handling or use.To further mitigate the potential risk and strengthen process controls, the following reinforcement actions have been taken: training has been conducted for all relevant personnel on proper cleanroom dressing procedures.Reinforcement of cleanroom gowning requirements through stricter sop enforcement, including personnel checks to ensure full compliance with protective clothing requirements.Replacement of current cleaning cloths with certified lint-free wipes for all equipment cleaning activities within controlled environments.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.Based on the determined risk priority number, the residual risk related to the complaint is considered acceptable.

• Brand Name: SOL-M
• 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. 501, shunfeng rd.,; linping district; 311106 hangzhou, zhejiang, ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago
• MDR Report Key: 25561754
• Report Number: 3014312726-2026-00044
• Device Sequence Number: 13285383
• Product Code: FMF
• UDI-Device Identifier: 00810062434305
• UDI-Public: (01)00810062434305(10)04510043,04510073
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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: 04510043, 04510073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2025
• 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