MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-M BLUNT FILL NEEDLE 18G*1 1/2"

Model Number	110022
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer complaint number: (b)(4).Customer reported that the rubber particles inside medicine vials and syringes.
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the archive sample 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.This report was initially submitted on 01/30/2025.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Additional Manufacturer Narrative
This report when initially submitted encountered an internal issue potentially related to database connectivity.This issue was identified while implementing capa-57 which was opened following an fda inspection.Scar 20241001 was initiated at the manufacturing site to track the investigation and application of corrective actions associated with the event.Corrective actions include optimization of sandblasting process and equipment, increase inspection sampling frequency, and update engineering drawings to clarify sandblasting requirements.Corrective actions were verified by inspection of 3 batchs produced after improvement implementation.This supplemental mdr is being submitted to correct the manufacturing site information provided in the initial mdr [3014312726-2025-00015].The previously reported site was incorrect.The correct manufacturing site is: zhejiang kindly medical devices co., ltd.No.758, 5th binhai road binhai industrial park longwan, wenzhou, zhejiang province.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M BLUNT FILL NEEDLE 18G*1 1/2"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer Contact: jarryd franklin ; no. 758, 5th binhai road; binhai industrial park; longwan ,wenzhou,, zhejiang province ; CH
• MDR Report Key: 22035693
• Report Number: 3014312726-2025-00015
• Device Sequence Number: 8733631
• Product Code: GAA
• UDI-Device Identifier: 00818392015294
• UDI-Public: (01)00818392015294
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 110022
• Device Lot Number: 02401091
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• 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