MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-M 1ML ALLERGY SYRINGE TRAY 27G*1/2

Model Number	181027T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the leak in the syringe where the syringe meets the needle.
Additional Manufacturer Narrative
Investigation in progress.No samples are available of the suspect device.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
The reported complaint regarding leakage at the needle hub of the sol-m 1ml allergy syringe tray 27g*1/2 was investigated through batch record review, archive sample analysis, and customer sample analysis.No abnormalities were identified in the manufacturing records, archived samples, or returned customer samples.All samples tested met acceptance criteria in visual inspection, clinical simulation, and leakage testing in accordance with iso 8537:2017 annex e.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.
Additional Manufacturer Narrative
This supplemental mdr is being submitted to removing the lot 07409056 provided in the initial mdr [3014312726-2025-00202].The previously reported lot 07409056 was incorrect.The correct lot is 02406108 only.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M 1ML ALLERGY SYRINGE TRAY 27G*1/2
• 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 ,wenzhou,, zhejiang province ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22974942
• Report Number: 3014312726-2025-00202
• Device Sequence Number: 8918153
• Product Code: FMF
• UDI-Device Identifier: 00818392014716
• UDI-Public: (01)00818392014716(10)02406108,07409056
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153537
• 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,Followup
• Report Date (Section B): 02/20/2026

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: 181027T
• Device Lot Number: 02406108,07409056
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/01/2025; 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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