MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-M; SOL-M 10ML LUER LOCK SYRINGE W/O NEEDLE

Model Number	P180010BS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the archive sample analysis.As part of our continuous process improvement plan, a random sampling strategy was reinforced for 27 identified batch numbers of syringe in bulk sterile, and the final product inspection was upgraded.The inspection involved 500 samples per lot (total 13,500 pcs) and confirmed full compliance with product specifications, with no cracked syringes detected.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.
Event or Problem Description
Customer reported during the procedure, two syringes cracked while the doctor was injecting saline during thermodilution measurements.Unfortunately, i am writing to confirm there are no photos/ videos or unused samples available, and customer did not keep defect sample.

• Brand Name: SOL-M
• Common Device Name: SOL-M 10ML LUER LOCK SYRINGE W/O NEEDLE
• 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: 24661670
• Report Number: 3014312726-2026-00019
• Device Sequence Number: 15759821
• Product Code: FMF
• UDI-Device Identifier: 00810018095161
• UDI-Public: (01)00810018095161(10)04503055
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K101359
• 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
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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: P180010BS
• Device Lot Number: 04503055
• 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: 02/27/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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