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

Model Number	110021
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported: according to the hospital´s nurses, noticing for several times, have been noticing the fact that while medication preparation aspiration of rubber particles was occurring.In fact, when penetrating the vial stopper and its posterior withdrawal of the medication they saw some particles floating inside the barrel of the syringe or in the medication container.Location: (b)(6) hospital.
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the return sample and 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 04/08/2024.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.This supplemental mdr is being submitted to correct 510(k) number (g4) provided in the initial mdr 3014312726-2024-00195.The previously reported 510(k) number (g4) was incorrect.The correct 510(k) number (g4) is not applicable for gaa class i medical device.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-M BLUNT FILL NEEDLE 18G*1"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 311 south wacker drive; suite 4100; chicago IL 60606
• Manufacturer (Section G): SOL-KL (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED; xinpan road 189; xinqiao; songjiang, shanghai 20161 2; CH 201612
• Manufacturer Contact: jarryd ; 311 south wacker dr.; suite 4100; chicago 60606
• MDR Report Key: 22035520
• Report Number: 3014312726-2024-00195
• Device Sequence Number: 12925617
• Product Code: GAA
• UDI-Device Identifier: 10818392013907
• UDI-Public: (01)10818392013907(10)05108036
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K112777
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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 Expiration Date: 08/27/2026
• Device Model Number: 110021
• Device Lot Number: 05108036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• 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