MAUDE Adverse Event Report: Terumo Philippines Corporation SurGuard3 Safety Hypodermic Needle (McKesson Label); NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	102-N251S3
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction

• Brand Name: SurGuard3 Safety Hypodermic Needle (McKesson Label)
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): Terumo Philippines Corporation; 124 east main avenue; laguna technopark; biñan laguna, 4024 ; RP 4024
• Manufacturer (Section G): Terumo Philippines Corporation; 124 east main avenue; laguna technopark; biñan laguna, 4024 ; RP 4024
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; +1(949)989-0491
• MDR Report Key: 50452126
• Report Number: 3003902955-2026-00086
• Device Sequence Number: 16073991
• Product Code: FMI
• UDI-Device Identifier: 10612479246390
• UDI-Public: (01)10612479246390(17)291130(10)241211C
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: 102-N251S3
• Device Catalogue Number: N/A
• Device Lot Number: 241211C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2024
• 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