MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-M; NEEDLE, SAFETY 25GX1" (HINGED STYLE)

Model Number	16-N251S
Medical Device Problem Code	Decoupling (1145)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation, no abnormalities or deviations were identified in the batch records or archived samples of the reported lot (csod12-05).All samples tested, including visual inspection, simulation of use, and iso 80369-7 performance tests, met the acceptance criteria.As no sample or picture was received from the customer, the reported issue could not be directly verified.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.
Event or Problem Description
Customer reported that the medical assistant drew up the pentacel with the 25g x5/8 in syringe with safety hypodermic needle 1cc and then attached the 25g x 1 inch (mfr 16-n251s; lot csod12-05) to the syringe to administer the vaccine.When giving the vaccine to the patient the needle broke off the syringe and the vaccine spilled out.

• Brand Name: SOL-M
• Common Device Name: NEEDLE, SAFETY 25GX1" (HINGED STYLE)
• 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: 23766978
• Report Number: 3014312726-2025-00208
• Device Sequence Number: 10593907
• Product Code: FMI
• UDI-Device Identifier: 10612479244624
• UDI-Public: (01)10612479244624(10)CSOD12-05
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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: 16-N251S
• Device Lot Number: CSOD12-05
• 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: 11/11/2025
• Initial Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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