MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-M 3ML LUER LOCK SYRINGE W/O NEEDLE (BULK, STERILE)

Model Number	P180003BS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
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.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.Unconfirmed.This report was initially submitted on 01/24/2025.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
"the customer reported that the syringe snapped under reasonable pressure, whilst administering fluids to the eye during cataract surgery.No harm came to the patient or surgical team.A different syringe was used and there was a small delay whilst this product was retrieved.Additional details: was medical or surgical intervention required due to the issue? no.Was surgery or therapy delayed while the patient was under anesthesia? no.
Additional Manufacturer Narrative
This report when initially submitted encountered an internal issue potentially related to database connectivity.This issue was identified while implementing capa-57 which was opened following an fda inspection.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M 3ML LUER LOCK SYRINGE W/O NEEDLE (BULK, STERILE)
• 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: jarryd franklin ; 311 s. wacker dr; suite 4100; chicago
• MDR Report Key: 22035669
• Report Number: 3014312726-2025-00010
• Device Sequence Number: 8788369
• Product Code: FMF
• UDI-Device Identifier: 00810018095123
• UDI-Public: (01)00810018095123
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K101359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: P180003BS
• Device Lot Number: 04405109
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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