MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-CARE; SOL-CARE SAFETY NEEDLE 25G*5/8"

Model Number	SN2558
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of the date of this report, no samples of the impacted sol-care safety needle 25g × 5/8" (ref # sn (b)(6), lot# 02509022) have been received from the customer for evaluation.The tested retained samples confirmed full compliance with product specifications, including simulation of protective arm activation using both thumb pressure and a hard surface.Due to this reason, we were unable to replicate the reported issue during our testing.Based on the investigation of the received pictures, the needle appears to be fully engaged with the hook of the safety arm.In addition, the needle tip is not protruding beyond the safety arm and is completely covered.As observed from the images, there is no visible evidence supporting the reported issue.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 security did not close correctly and the needle hurt the user on the hand.

• Brand Name: SOL-CARE
• Common Device Name: SOL-CARE SAFETY NEEDLE 25G*5/8"
• 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, 325025 wenzhou, zhejiang 32502 5; CH 325025
• Manufacturer Contact: intheran annadurai ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 25158751
• Report Number: 3014312726-2026-00035
• Device Sequence Number: 9453223
• Product Code: FMI
• UDI-Device Identifier: 00818392010480
• UDI-Public: (01)00818392010480(10)02509022
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123684
• 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
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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: SN2558
• Device Lot Number: 02509022
• 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: 04/14/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2025
• 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