MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC HENRY SCHEIN; HENRY SCHEIN SAFETY NEEDLE 18G*1''

Model Number	570-2693
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/19/2025
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.
Event or Problem Description
The customer reports that a 39-year-old male paramedic was drawing up medication and was wearing gloves.The safety clasp was not engaging.This then resulted in a needlestick injury from a used needle.It was not documented if the person wearing had any open cuts.The paramedic cleaned the area with soap and water and applied bandage to the area.

• Brand Name: HENRY SCHEIN
• Common Device Name: HENRY SCHEIN SAFETY NEEDLE 18G*1''
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): PROMISEMED HANGZHOU MEDITECH CO.,LTD; no.1388 cangxing street; cangqian community,yuhang dist; hangzhou city, zhejiang ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22870264
• Report Number: 3014312726-2025-00190
• Device Sequence Number: 9081516
• Product Code: FMI
• UDI-Device Identifier: 10304040154059
• UDI-Public: (01)10304040154059(10)07307021
• 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): 08/22/2025

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: 570-2693
• Device Lot Number: 07307021
• 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: 07/26/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2021
• 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