MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-M; SOL-M TUBE HOLDER WITH LUER LOCK ADAPTER

Model Number	110201050003
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the blood return is inconsistent and occasionally has blood leakage when connected to the blue hub.
Additional Manufacturer Narrative
Based on the results of the investigation including batch record review, archive sample analysis, and risk assessment no abnormalities were identified in the production or quality control processes.All tested samples met the acceptance criteria per iso 80369-7:2021 requirements and showed no leakage or functional defects during testing.The reported issue could not be reproduced under controlled conditions, indicating that the event is isolated and not attributable to a manufacturing or design deficiency.Additionally, our risk evaluation, conducted in accordance with iso 14971, indicates that the residual risk associated with this failure mode is low.No trends related to this issue have been identified during our track-and-trend analysis.

• Brand Name: SOL-M
• Common Device Name: SOL-M TUBE HOLDER WITH LUER LOCK ADAPTER
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.; no. 758, 5th binhai road; binhai industrial park; longwan ,wenzhou,, zhejiang province ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 23988086
• Report Number: 3014312726-2026-00001
• Device Sequence Number: 4554471
• Product Code: FMI
• UDI-Device Identifier: 00818392018158
• UDI-Public: (01)00818392018158(10)02103075
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182146
• 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): 01/07/2026

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 Expiration Date: 04/10/2026
• Device Model Number: 110201050003
• Device Lot Number: 02103075
• 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: 12/09/2025
• Initial Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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