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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No samples and pictures of impacted sol-m tube holder with luer lock adapter, ref# 110201050003 and lot# 05302015, were received from the customer for evaluation.All the retained samples tested were confirmed full compliance with product specifications.Batch number 05302015 was tested for separation force test and confirmed to have met the specified physical performance requirements by meeting acceptance criteria.Archive samples passed the overload resistance and anti-slip testing in accordance with iso 80369-7:2021 and all the tested samples were under product specification.It is not known which other medical device the holder had been connected to, nor how it was handled prior to receipt for example, whether excessive force or over-torquing may have been applied.As these conditions are unknown, the possibility of user related or handling related damage cannot be excluded.Due to this reason, the root cause could not be determined with certainty.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.As part of our continued commitment to our customers, sol millennium will continue to monitor the complaints trend for the reported failure mode and take any corrective action based on our procedures, if a significant pattern emerges.
Event or Problem Description
Customer reported that the luer-lock connector broke involving an important blood leakage on the floor in icu.

• 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): SOL-KL (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED; xinpan road 189; xinqiao; songjiang, shanghai 20161 2; CH 201612
• Manufacturer Contact: intheran annadurai ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 24634539
• Report Number: 3014312726-2026-00020
• Device Sequence Number: 18355904
• Product Code: FMI
• UDI-Device Identifier: 00818392018158
• UDI-Public: (01)00818392018158(10)05302015
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

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: 110201050003
• Device Lot Number: 05302015
• 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: 02/18/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• 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