MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-M 1ML LUER LOCK SYRINGE W/O NEEDLE (PP) (LOW DEAD SPACE)

Model Number	P180001PP
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation in-progress.
Event or Problem Description
Customer reported that the brown residue on the inside of the barrel of this syringe.
Additional Manufacturer Narrative
Based on the review of device history file, no abnormalities were found.In the customer sample, a brown substance was observed on the plunger, but not inside the barrel.The red/brown stains are likely due to lubricating oil used in the injection molding machinery.It is suspected that, during the molding process, the plastic component met the oil on the machine during mold detachment.This is considered an isolated incident.As a preventive measure, the manufacturing partner has implemented the use of plastic film near the injection molding machine to prevent contact between the components and machine surfaces during mold release, thereby reducing the risk of recurrence.Additionally, our risk evaluation, conducted in accordance with iso 14971, indicates that the residual risk associated with this failure mode is low.Therefore, the residual risk related to this complaint is deemed acceptable based on the calculated risk priority number.This assessment is supported by our trend analysis and risk management documentation, which are regularly reviewed and updated as part of our post-market surveillance activities.Sol-millennium remains committed to product quality and customer satisfaction.We will continue to monitor this product category for any trends or recurring issues and will take appropriate action should new information become available.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M 1ML LUER LOCK SYRINGE W/O NEEDLE (PP) (LOW DEAD SPACE)
• 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, IL 60606
• MDR Report Key: 22182344
• Report Number: 3014312726-2025-00134
• Device Sequence Number: 8505965
• Product Code: FMF
• UDI-Device Identifier: 00818392018165
• UDI-Public: (01)00818392018165(10)04106075
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: 06/30/2026
• Device Model Number: P180001PP
• Device Lot Number: 04106075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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