MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. SOL-MILLENNIUM; SOL-M 1ML INSULIN SYRINGE W/FIXED NEEDLE 27G*1/2

Model Number	1612712B
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No anomalies were found on sol-m 1ml insulin syringe w/fixed needle 27g*1/2(u-100 insulin only)(pe bag) ref 1612712b lot 04004020 archived samples checked.All the values obtained from tests performed comply with the specification, this suggests that archive samples are functioning as intended and are suitable for their intended purpose.Without involved samples, knowledge of the clinical procedure and any useful evidence we cannot perform further investigation.Sol-millennium will continue to monitor this type of issue and if data will increase, further evaluation will be performed.This report was initially submitted on 05/20/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
Customer reported: uncapped syringes when opening the package of 100 syringes, stick by an employee.
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.This supplemental mdr is being submitted to correct "report type (b1) and common device name (d2a)" provided in the initial mdr.The previously reported report type is adverse event and product problem, common device name: sol-m quincke spinal needle 25gx 3.5" was incorrect.The correct report type is product problem only and common device name (d2a) is sol-m 1ml insulin syringe w/fixed needle 27g*1/2.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M 1ML INSULIN SYRINGE W/FIXED NEEDLE 27G*1/2
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 311 south wacker drive; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG LONGDE PHARMACEUTICAL CO., LTD.; no. 501, shunfeng rd; linping district; zhejiang, hangzhou 31110 6; CH 311106
• Manufacturer Contact: jarryd ; 311 south wacker dr.; suite 4100; chicago 60606
• MDR Report Key: 22035561
• Report Number: 3014312726-2024-00234
• Device Sequence Number: 21027380
• Product Code: FMF
• UDI-Device Identifier: 00810018090005
• UDI-Public: 00810018090005
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2025
• Device Model Number: 1612712B
• Device Lot Number: 04004020
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown