MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; HENRY SCHEIN 3ML LUER LOCK SYRINGE W/SAFETY NEEDLE 25G*1

Model Number	900-7644
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the patients were having routine b12 and lipo-b injections in their upper arms when they noticed that the needles are hurting more when they are being pulled out.This has also caused excessive bruising to the patients.None of them required medical attention or medical treatment.
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the archive sample analysis.Based on the determined risk priority number, the residual risk related to the complaint is considered acceptable.Sol millennium continues to monitor this kind of issue.Additional assessment will be taken if a significant pattern emerges.Unconfirmed.
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the analysis on the archive samples and devices from same lot returned from customer.Based on the determined risk priority number, the residual risk related to the complaint is considered acceptable.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.Sol millennium continues to monitor this kind of issue.Additional assessment will be taken if a significant pattern emerges.Unconfirmed.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: HENRY SCHEIN 3ML LUER LOCK SYRINGE W/SAFETY NEEDLE 25G*1
• 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 district 325025 wenzho, zhejiang ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22226655
• Report Number: 3014312726-2025-00133
• Device Sequence Number: 18269050
• Product Code: FMF
• UDI-Device Identifier: 00304040017098
• UDI-Public: (01)00304040017098(10)01106082
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K241821
• 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): 07/16/2025

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: 06/20/2026
• Device Model Number: 900-7644
• Device Lot Number: 01106082
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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