MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC HENRY SCHEIN; HENRY SCHEIN SAFETY NEEDLE 25G*1''

Model Number	570-2703
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation, no deviations were observed in the device history record, archived sample analysis, or performance testing of the henry schein safety needle 25g*1'' (ref: 570-2703, lot: 07504017).All tested samples met specifications, and the device functioned as intended during simulated clinical use.No product-related nonconformities were identified.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.Our risk evaluation, conducted in accordance with iso 14971, indicates that the residual risk associated with this failure mode is low.Therefore, the residual risk related to this complaint is deemed acceptable based on the calculated risk priority number.
Event or Problem Description
Customer reports that they had a recent needlestick injury.They are unable to determine which of these lots caused the needlestick injury as these lots were in the bin the needle was stocked in and the packaging was not saved when it was being used.
Additional Manufacturer Narrative
This supplemental mdr is being submitted to add an additional lot number (lot: 07501025) that was not included in the initial mdr [3014312726-2026-00009].Upon further review, an additional affected lot number was identified and is being provided in this supplemental report.

• Brand Name: HENRY SCHEIN
• Common Device Name: HENRY SCHEIN SAFETY NEEDLE 25G*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: 24398998
• Report Number: 3014312726-2026-00009
• Device Sequence Number: 8132754
• Product Code: FMI
• UDI-Device Identifier: 10304040154172
• UDI-Public: (01)10304040154172(10)07504017
• 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): 03/16/2026

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: 570-2703
• Device Lot Number: 07501025
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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