MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-M; MONOJECT HYPODERMIC SAFETY NEEDLE 25G*5/8"

Model Number	1182558
Medical Device Problem Codes	Decoupling (1145); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the results of the investigation, no abnormalities were observed in the archived samples or in the reviewed batch manufacturing records.All dimensional and functional tests (including luer lock dimensional verification and resistance to separation tests per iso 80369-7:2021) met the specified requirements.The reported complaint could not be confirmed, as all tested samples met product specifications and performed as intended.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 during the injection of the varivax, towards the end of the injection volume amount, the needle separated/unscrewed itself from the syringe.The remaining volume of varivax leaked out of the syringe and was subsequently not administered to the patient.Approximately 0.1ml-0.2 ml appeared to be the amount that leaked out.Patient received majority of total volume amount.It appears that the needle and syringe did not have a good seal, despite my efforts of ensuring a sufficient seal x 2 (before drawing up the vaccine and after drawing up the vaccine), leading to the detachment of the two devices during the injection.Md notified, i discussed with dad that i felt as if the patient received the majority of the volume injection and dad agreed.

• Brand Name: SOL-M
• Common Device Name: MONOJECT HYPODERMIC SAFETY NEEDLE 25G*5/8"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.; no. 758, 5th binhai road; binhai industrial park; longwan ,wenzhou,, zhejiang province ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 24092472
• Report Number: 3014312726-2026-00005
• Device Sequence Number: 10468657
• Product Code: FMI
• UDI-Device Identifier: 10884521544710
• UDI-Public: (01)10884521544710(10)02408026
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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: 1182558
• Device Lot Number: 02408026
• 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: 12/18/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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