MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC MONOJECT; MONOJECT HYPODERMIC SAFETY NEEDLE 21G*1

Model Number	1182110
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
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.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.Sol millennium continues to monitor this kind of issue.Additional assessment will be taken if a significant pattern emerges.Unconfirmed.
Event or Problem Description
Customer reported that they were having issues with this needle leaking.When their lab was drawing blood, the blood starts running out the side of the needle down the patient's arm.The customer also stated that this is also happening with medication being administered to patients.
Additional Manufacturer Narrative
Tests performed on the received samples of monoject hypodermic safety needle ref 1182110, lot 02305014 confirmed that the devices are suitable for use.All components were present and properly assembled.The needle/syringe combinations (both luer lock and luer slip) were found to be compliant with iso 80369-7, and no liquid leakage was detected during simulation testing.Unconfirmed.

• Brand Name: MONOJECT
• Common Device Name: MONOJECT HYPODERMIC SAFETY NEEDLE 21G*1
• 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: 22574109
• Report Number: 3014312726-2025-00166
• Device Sequence Number: 9681427
• Product Code: FMI
• UDI-Device Identifier: 10884521544628
• UDI-Public: (01)10884521544628(10)02305014
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 1182110
• Device Lot Number: 02305014
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2023
• 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