MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-M 60ML LUER LOCK SYRINGE W/O NEEDLE (BULK, STERILE)

Model Number	P180060BS
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that something red was found inside the (second) 60ml syringe.The syringes were clean, and anesthetic had been drawn.The red substance was noticed in the operating room before drawing the anesthetic.
Additional Manufacturer Narrative
Our evaluation of the risk, which follows guidance from iso 14971, indicates that the overall risk for the reported failure is low.This evaluation is based on our track and trend analysis and risk management files which are evaluated and updated constantly based on post market surveillance.However, sol millennium decided to open a supplier corrective action request to the supplier for further investigation of the issue.All actions will be followed in the scar number: 20250301.Once the scar report is available a detailed corrective action will be shared.This report was initially submitted on 04/16/2025.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.This supplemental mdr is being submitted to correct all manufacturer contact office information provided in the initial mdr [3014312726-2025-00071].The previously reported was incorrect.The correct manufacture contact information is below; (b)(4), qa engineer, sol-millennium medical inc 311 s.Wacker dr., suite 4100 chicago, il 60606 united states (b)(4).

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M 60ML LUER LOCK SYRINGE W/O NEEDLE (BULK, STERILE)
• 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: 22035736
• Report Number: 3014312726-2025-00102
• Device Sequence Number: 8733658
• Product Code: FMF
• UDI-Device Identifier: 00810018095239
• UDI-Public: (01)00810018095239
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: P180060BS
• Device Lot Number: 04405022
• 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: 04/16/2025
• 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: 05/31/2024
• 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