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

Catalog Number	16-N251S
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that they have experienced three incidents where needles bent when the safety cap was applied after injection.The bending occurs because the needle tip is striking an internal component of the safety cap, rather than gliding smoothly as intended; there's no needlestick injuries have resulted from these incidents.Additionally, no information was received regarding a serious injury as a result of this product issue.

• 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: 21160722
• Report Number: 1451040-2025-00003
• Device Sequence Number: 12655894
• Product Code: FMI
• UDI-Device Identifier: 10612479244624
• UDI-Public: 10612479244624
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 01/15/2025
• Report Date (Section F): 01/15/2025

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: CSOB01-04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/24/2024
• Device Age: 36 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2025
• 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: 01/15/2025