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.
Additional Manufacturer Narrative
A2: date of birth: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual sample was received.The proximal end of the broken catheter was received.The tube was raggedly cut, slightly elongated, and pinched.The remaining tube approximately measures 1mm from the hub tip.The sample contained traces of blood.Retention samples were visually inspected and found to be free of any catheter damage that could have caused the complaint.The samples underwent a catheter tube and catheter hub fitting force test.The expected result is that either the catheter tube will be removed/separated from the catheter hub, or the catheter tube will break during the test (test is in reference to iso 10555-1).Results were all passed against our specification of >7.845n.There was no issued nonconformity report related to human error during lot production.The reported item code is produced at a semi-automated line.During catheter assembly, the catheter is cut to the desired length, and the flange is formed and pressed into the catheter hub.The catheter's tip is then formed.Based on the sr machine downtime history, there are no related machine troubles that could have caused the complaint.We perform initial quality confirmation through visual inspection and functional tests before mass production.During visual inspection 1, all products are checked for damaged or deformed catheter tube conditions.The catheter tube and catheter hub fitting test is conducted during the production process.Visual in-process inspections were conducted during 100% visual inspections to check the catheter tube condition.Before shipment, we have an outgoing inspection to check the overall condition of the product.The catheter tube undergo incoming inspection, which includes visual inspection and verification of the certificate of analysis according to the material specification.From the previous two fiscal years to the present, 61% catheter tube breakage complaints are related to usage.The result of the investigation showed that there was no attributable cause noted related to our product or the manufacturing process.The reported device was used with no difficulty during the medical procedure, and there were no issues during placement; the catheter was placed as intended.The condition of the damage suggests that excessive physical force was the reason for the breakage.The ragged and pinched ends are consistent with forceful pulling or twisting, which may have occurred during patient repositioning, accidental tugging, or improper handling during catheter adjustment or removal.Our catheter tube has high tensile strength and does not break easily, even when a strong force is applied.We have routine inspections to check the condition of the products.We conduct an outgoing inspection prior to shipment to ensure the overall condition of the catheters.Therefore, our process is assured.(b)(4)) (importer) registration no.(b)(4) is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.(b)(4).Please refer to section h10 for the importer's report on the reported event.

• 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
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan laguna, 4024 ; RP 4024
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 23306993
• Report Number: 3003902955-2025-00082
• Device Sequence Number: 5135546
• 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
• PMA/510(K) Number: K133280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 141 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White