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 Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that after using the empty syringe for blood collection, irregular crackswere found on the outer barrel of the syringe, indicating a need to enhance quality control.Customer reported that the syringe barrel is cracked.
Additional Manufacturer Narrative
Based on the investigation, no abnormalities were detected during the analysis of the samples archived.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.It is believed that the crack may have been caused by unexpected pressure from the assembly machine during production.Additionally, the defective product may have gone undetected due to oversight by on-line inspectors as a corrective action, all inspectors will be retrained and educated to carefully inspect each product individually, with a specific focus on identifying any breakage or defects.Defective products must be promptly isolated and scrapped to prevent them from reaching customers.Additionally, our risk evaluation, conducted in accordance with iso 14971, indicates that the residual risk associated with this failure mode is low.Therefore, the residual risk related to this complaint is deemed acceptable based on the calculated risk priority number.This assessment is supported by our trend analysis and risk management documentation, which are regularly reviewed and updated as part of our post-market surveillance activities.As part of our ongoing commitment to customer safety and product quality, sol-millennium will continue to monitor for this type of failure.If a recurring trend is identified, further batch and sample evaluations will be conducted at our manufacturing facility.

• 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: 22294681
• Report Number: 3014312726-2025-00089
• Device Sequence Number: 8458224
• Product Code: MEG
• UDI-Device Identifier: 00818392015041
• UDI-Public: (01)00818392015041(10)04310058,04405087
• 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: 04310058 ,04405087
• 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: 11/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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