MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-M 10ML ORAL DISPENSING SYRINGE CLEAR W/TIP CAP

Model Number	21010GCNSB
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
"please note that oral syringes ref# 21010gcnsb failed our client first production testing due to capacity - volumetric oos, please see details below: the submitted sample(s) did not meet the capacity - volumetric requirements for the following: claim: 10 ml, spec: min: 9.6 ml, actual test results: 9.4 ml.".
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the return sample and 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 08/19/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
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 10ML ORAL DISPENSING SYRINGE CLEAR W/TIP CAP
• 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 hangz; zhejiang, ; CH
• Manufacturer Contact: jarryd franklin ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22035546
• Report Number: 3014312726-2024-00297
• Device Sequence Number: 18337525
• Product Code: KYX
• UDI-Device Identifier: 00810018097912
• UDI-Public: (01)00810018097912
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: 21010GCNSB
• Device Lot Number: 04312029
• 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: 08/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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