MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. MCKESSON BRANDS; NEEDLE, SAFETY PREVENT HT 25GX5/8"

Catalog Number	16-N2558S
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the needles experienced a malfunction in the safety feature, which does not close properly.This issue causes the needle to bend and pierce through the safety cover.There was one incident where this resulted in a needlestick to an employee.

• Brand Name: MCKESSON BRANDS
• Common Device Name: NEEDLE, SAFETY PREVENT HT 25GX5/8"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; lawrenceville,; GA 30043
• MDR Report Key: 21709700
• Report Number: 1451040-2025-00015
• Device Sequence Number: 9941543
• Product Code: FMI
• UDI-Device Identifier: 10612479244655
• UDI-Public: 10612479244655
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/27/2025
• Report Date (Section F): 03/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 16-N2558S
• Device Lot Number: CSOD05-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/19/2025
• Device Age: 8 MO
• Event Location: Other
• Date Report to Manufacturer: 03/27/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2025
• 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: 03/27/2025