MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-CARE 10ML LUER LOCK SAFETY SYRINGE W/EXCH NEEDLE 21G*

Model Number	TW160072IMLD
Medical Device Problem Codes	Contamination (1120); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation conducted using archived sample analysis, no evidence of quality issues directly related to this complaint was identified.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.However, the factory identified potential root causes for the reported issue of foreign material contamination.These include the possible presence of plastic chips from the injection molding process, likely due to insufficient cleaning of equipment and molds, as well as potential contamination from human hair, possibly resulting from improper use of protective clothing by assembly personnel.In both cases, inadequate inspection may have contributed to defective products being released to the market.As a corrective actions, retrain and educate all inspectors, required to check each product one by one, focusing on the foreign matter in the product, and isolating and scrapping defective products in time.Strengthen the cultivation of the sense of responsibility and quality awareness of inspectors.Sol-millennium will continue to monitor complaint trends related to this failure mode and will initiate corrective actions in accordance with internal procedures if a significant pattern emerges.This report was initially submitted on 04/06/2025.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
Customer reported that they when opening the needle for use, it was found that there was foreign matter (plastic block) inside the empty needle.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-CARE 10ML LUER LOCK SAFETY SYRINGE W/EXCH NEEDLE 21G*
• 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. 501, shunfeng rd.,; linping district; 311106 hangzhou, zhejiang, ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22294680
• Report Number: 3014312726-2025-00077
• Device Sequence Number: 18257305
• Product Code: MEG
• UDI-Device Identifier: 00818392015041
• UDI-Public: (01)00818392015041(10)04405082
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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: TW160072IMLD
• Device Lot Number: 04405082
• 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: 12/25/2024
• Initial Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2024
• 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