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

Model Number	570-2703
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation found no abnormalities in the batch record, visual inspection, or functional testing of archive samples (patency, clinical simulation, and fragmentation).All tested units met acceptance criteria.The in-process control system, which includes needle patency verification, was confirmed capable of detecting non-conforming products.The issue could not be confirmed, and without the customer's sample the root cause could not be determined.Based on the risk assessment, the residual risk is considered acceptable, and no related trends were identified in track-and-trend analysis.
Event or Problem Description
Customer reported:"on 10/09/2025 (b)(6) discovered on the fda maude database a voluntary report filed under mw5176404.Per the report "patient presented for an influenza vaccine.Needle (b)(6) safety needle 25g 1) was correctly placed onto influenza vaccine syringe, maintaining sterile technique.Patient's skin was prepped with isopropyl alcohol swab.Needle (attached to influenza vaccine syringe) was inserted into patient's skin, but plunger would not move.Needle (attached to influenza vaccine syringe) was then withdrawn, and needle was replaced with a new needle.(b)(6) safety needle 25g) maintaining sterile technique.Patient's skin was again prepped with isopropyl alcohol swab.After that, new needle (attached to influenza vaccine syringe) was inserted into patient's skin, and plunger of syringe worked as intended.Influenza vaccine was then successfully administered to patient.Patient tolerated procedure well".The patient was a 15 year old, sex of patient unknown, patient ethnicity is non hispanic, and patient race is white.The end user of this product is unknown and reason it is not populated on this event report, we documented this under (b)(6) instead.".

• 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: 23495086
• Report Number: 3014312726-2025-00194
• Device Sequence Number: 8904385
• Product Code: FMI
• UDI-Device Identifier: 10304040154172
• UDI-Public: (01)10304040154172(10)07501025
• 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): 11/07/2025

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: 570-2703
• 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: 10/09/2025
• Initial Report FDA Received Date: 11/07/2025
• 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 Age: 15 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White