MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC MCKESSON; NEEDLE, BLUNT FILL 18GX1 1/2"

Model Number	16-305180
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the blunt fill needles have been coring the rubber stoppers on vials.
Additional Manufacturer Narrative
Based on the customer-provided picture, the issue has been confirmed.However, no quality issues were identified during the archive sample analysis.Therefore, the issue could not be confirmed through internal evaluation.Based on the determined risk priority number (rpn), the residual risk associated with this complaint is considered acceptable.Additionally, no trends related to this issue have been identified during our track-and-trend analysis.Sol-millennium will continue to monitor for similar issues, and further assessment will be conducted if a significant pattern emerges.
Additional Manufacturer Narrative
The complaint related to coring with the blunt fill needle 18gx1½" (ref: (b)(4), lot: csod11-01) has been confirmed based on customer-provided evidence.However, no abnormalities were identified during the batch record review, archive sample testing, or customer sample analysis.All samples met product specifications and passed relevant tests, including visual inspection, coring, and fragmentation per iso 7864:2016(e).

• Brand Name: MCKESSON
• Common Device Name: NEEDLE, BLUNT FILL 18GX1 1/2"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer (Section G): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO.; no 658; gaochao road201803; shanghai, ; CH
• Manufacturer Contact: mohanapriya kannupaiyan ; 311 s. wacker dr; suite 4100; chicago, IL 60606
• MDR Report Key: 22585509
• Report Number: 3014312726-2025-00170
• Device Sequence Number: 9340802
• Product Code: GAA
• UDI-Device Identifier: 00612479230859
• UDI-Public: (01)00612479230859(10)CSOD11-01
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 08/07/2025

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: 16-305180
• Device Lot Number: CSOD11-01
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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