MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. MCKESSON BRANDS; NEEDLE, SAFETY PREVENT HT 25GX1"

Catalog Number	16-N251S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This issue was brought to our attention by ecri (emergency care research institute), although the customer who encountered the issue has chosen to remain anonymous.
Event or Problem Description
It was reported by the customer that two safety needles of the same lot broke in patients during vaccinations, the needles were safely removed by hand, no patient injuries were sustained as a result of this incident.

• Brand Name: MCKESSON BRANDS
• Common Device Name: NEEDLE, SAFETY PREVENT HT 25GX1"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; lawrenceville,; GA 30043
• MDR Report Key: 21661859
• Report Number: 1451040-2025-00012
• Device Sequence Number: 20900903
• Product Code: FMI
• UDI-Device Identifier: 10612479244624
• UDI-Public: 10612479244624
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2025
• Report Date (Section F): 03/21/2025

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 Catalogue Number: 16-N251S
• Device Lot Number: CSOD10-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/06/2025
• Device Age: 5 MO
• Event Location: Other
• Date Report to Manufacturer: 03/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/21/2025