MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC HENRY SCHEIN; HENRY SCHEIN 3ML LUER LOCK SYRINGE W/SAFETY NEEDLE 25G*1 1/2

Model Number	900-7647
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
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.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.Based on the determined risk priority number, the residual risk related to the complaint is considered acceptable.Sol millennium continues to monitor this kind of issue.Additional assessment will be taken if a significant pattern emerges.Unconfirmed.
Event or Problem Description
The customer advised that these syringes do not expire until 2026, however the needles are dull and are not working properly.
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the customer sample analysis.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.Based on the determined risk priority number, the residual risk related to the complaint is considered acceptable.Sol millennium continues to monitor this kind of issue.Additional assessment will be taken if a significant pattern emerges.Unconfirmed.

• Brand Name: HENRY SCHEIN
• Common Device Name: HENRY SCHEIN 3ML LUER LOCK SYRINGE W/SAFETY NEEDLE 25G*1 1/2
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO.; no 658; gaochao road201803; shanghai, ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22226574
• Report Number: 3014312726-2025-00129
• Device Sequence Number: 8570364
• Product Code: FMF
• UDI-Device Identifier: 00304040017128
• UDI-Public: (01)00304040017128(10)01106083
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K241821
• 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): 07/09/2025

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 Expiration Date: 06/20/2026
• Device Model Number: 900-7647
• Device Lot Number: 01106083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• 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