MAUDE Adverse Event Report: Terumo Surflo Winged Infusion Set with Needle Protection; Set, Administration, Intravascular

Model Number	SV-S25FL35
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: Terumo Surflo Winged Infusion Set with Needle Protection
• Common Device Name: Set, Administration, Intravascular
• Manufacturer Contact: christopher karner ; 500 kendall st.; cambridge, MA 02142 ; +1(949)291-2843
• MDR Report Key: 50909436
• Report Number: 2032282-2026-00154
• Device Sequence Number: 6076662
• Product Code: FPA
• UDI-Device Identifier: 05413206054947
• UDI-Public: 05413206054947
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/26/2026

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: SV-S25FL35
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/26/2026
• 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 Age: 10 YR
• Patient Sex: Male
• Patient Race: White