MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-M; SOL-M 10ML LUER LOCK SYRINGE W/EXCH NEEDLE 21G*1

Model Number	1812110
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation, which included a batch record review, visual inspection, and simulation of clinical use, no abnormalities were identified in the manufacturing process or in the product quality of the affected batch.All tested samples met the specified requirements and successfully passed all verification tests.Additionally, our risk evaluation, conducted in accordance with iso 14971, indicates that the residual risk associated with this failure mode is low.No trends related to this issue have been identified during our track-and-trend analysis.
Event or Problem Description
Customer reported that the sol-millennium syringe "split" during the injection of product from the syringe into an iv bag.

• Brand Name: SOL-M
• Common Device Name: SOL-M 10ML LUER LOCK SYRINGE W/EXCH NEEDLE 21G*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. 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: 24505400
• Report Number: 3014312726-2026-00013
• Device Sequence Number: 16056295
• Product Code: FMF
• UDI-Device Identifier: 00818392010244
• UDI-Public: (01)00818392010244(10)04312071
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K241821
• 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): 03/04/2026

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: 1812110
• Device Lot Number: 04312071
• 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: 02/03/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2023
• 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