MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC HENRY SCHEIN; HENRY SCHEIN 3ML LUER LOCK SYRINGE W/EXCH NEEDLE TRAY 21G*1

Model Number	900-7842
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No physical samples were returned to sol-millennium for evaluation; therefore, the investigation was conducted based on review of the provided images, batch record review, archived sample analysis, and risk assessment activities.Due to the absence of returned samples, it was not possible to conclusively determine the nature or exact origin of the reported foreign matter.In addition, based on the available photographs, it could not be determined with certainty whether the observed contamination was located externally on the syringe or within the administration area.All retained samples evaluated from the affected lot were found compliant with applicable product specification requirements, and the reported issue could not be reproduced under controlled assessment conditions.Enhanced training was also provided to operators and final inspectors, with strict adherence to hygiene practices reinforced to help prevent recurrence of foreign matter defects.As a precautionary measure, considering that the possibility of foreign matter being present within the administration area could not be excluded, the event was determined to be reportable and an mdr was submitted to fda.
Event or Problem Description
Customer reported that they received the product with a foreign matter encased in the package.

• Brand Name: HENRY SCHEIN
• Common Device Name: HENRY SCHEIN 3ML LUER LOCK SYRINGE W/EXCH NEEDLE TRAY 21G*1
• 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, 325025 wenzhou, zhejiang 32502 5; CH 325025
• Manufacturer Contact: intheran annadurai ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 25298861
• Report Number: 3014312726-2026-00034
• Device Sequence Number: 18471331
• Product Code: FMF
• UDI-Device Identifier: 00304040017203
• UDI-Public: (01)00304040017203(10)02311023
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: 900-7842
• Device Lot Number: 02310126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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