MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURFLO INTRAVENOUS CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	SR-OX2051CA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	09/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the following information: a patient underwent revision of an infected left total knee replacement on (b)(6) 2025.On (b)(6) 2025, a 20-gauge peripheral intravenous (iv) catheter was placed anteriorly in the left forearm by an anesthesiologist.Placement was routine via the first insertion attempt.Daily assessments were performed 3 - 4 times per day, with twice-daily flushing and capping.Fluids were delivered successfully from the time of placement with no issues noted until (b)(6) 2025 at 14:51, when the iv was found to be leaking during a dressing change performed by a registered nurse (rn).The rn observed that the catheter tip was missing from the main catheter tubing, with approximately 1 mm remaining.No blood loss was reported.Medwatch received by customer care on (b)(6) 2025.Medwatch number (b)(4)."required intervention to prevent permanent impairment/damage.Portable left forearm x-ray on (b)(6) 2025 impression was, 4.7 cm piece of tubing in the subcutaneous tissue of the volar aspect of the proximal forearm, the most proximal portion of which is at the level of the radial tuberosity.Ultrasound impression on (b)(6) 2025 was ultrasound of the left forearm demonstrates a foreign body consistent with an intravenous catheter fragment within the basilic vein at the proximal forearm.There is associated acute venous thrombosis, which is nearly occlusive.On (b)(6) 2025 vascular surgery service consulted; the entire length of the catheter and thrombus were visualized on bedside ultrasound, and the foreign body was removed successfully via bedside i & d.The foreign body (5 cm catheter) was sent to pathology.Pathology report of (b)(6) 2025 noted that the specimen consists of a creamy white plastic tubing that is approximately 5cm in length and 0.1 cm in diameter.The specimen is crimped focally vascular surgery follow-up on (b)(6) 2025 noted, wound exam without concern for hematoma, bleeding, or infection.This is the latest patient status information as of the time of preparation of this report.

• Brand Name: TERUMO SURFLO INTRAVENOUS CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan laguna, 4024 ; RP 4024
• MDR Report Key: 23306994
• Report Number: 2243441-2025-00058
• Device Sequence Number: 12045997
• Product Code: FOZ
• UDI-Device Identifier: 34806017512249
• UDI-Public: (01)34806017512249(17)291031(10)241110SD
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/15/2025
• Report Date (Section F): 10/15/2025

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 Model Number: SR-OX2051CA
• Device Catalogue Number: N/A
• Device Lot Number: 241110SD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/16/2025
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 141 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 10/15/2025