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

Model Number	SR-OX2032CA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported an incident where the tip of a catheter broke off from the hub inside a patient, and the tip was subsequently removed.Additional information received on 08 apr 2025: from the nurse manager includes the following details: on (b)(6) 2025, the patient was brought to the operating room for a left radial percutaneous fixation procedure to insert a pin on the right side and apply a splint on the left side.An iv was administered during the procedure.On (b)(6) 2025, the primary nurse removed the iv and discovered that the catheter had broken off inside the patient's arm.The entire catheter was broken inside the patient's arm, except for less than 1mm remaining on the hub.An ultrasound revealed the catheter in the upper arm, 1 cm deep.An emergency incision and drainage procedure were performed to remove the catheter.The patient received two stitches, experienced minimal blood loss, and remained stable before and after the procedure.The patient was discharged the same day.

• 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: 21980051
• Report Number: 2243441-2025-00020
• Device Sequence Number: 13035439
• Product Code: FOZ
• UDI-Device Identifier: 34806017512256
• UDI-Public: (01)34806017512256(17)270531(10)220618SD
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 F): 05/07/2025

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-OX2032CA
• Device Catalogue Number: N/A
• Device Lot Number: 220618SD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/07/2025
• Device Age: 33 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2025
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/07/2025