MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-CARE 3ML LUER LOCK SAFETY SYRINGE W/EXCH NEEDLE 23G*1''

Model Number	TW100077IMLD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
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.Based on the investigation, the potential root cause of the crack may be caused by accidental machine clamping during the assembly process, process inspectors missed to identify the defective product, resulting in defective product entering the market.To address and contain this issue, inspection operators were strengthened and trained in standardized operation, on-site operations, and improved their awareness of product quality.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 rear part of the needle hub fractured, rendering the product unusable.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-CARE 3ML LUER LOCK SAFETY SYRINGE W/EXCH NEEDLE 23G*1''
• 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.510 shunfeng road; linping district hangzhou; zhejiang, 31110 6; CH 311106
• Manufacturer Contact: intheran annadurai ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 22382252
• Report Number: 3014312726-2025-00154
• Device Sequence Number: 8411292
• Product Code: MEG
• UDI-Device Identifier: 00818392015027
• UDI-Public: (01)00818392015027(10)04410073
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K092430
• 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): 07/02/2025

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: TW100077IMLD
• Device Lot Number: 04410073
• 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: 06/05/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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