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
Additional Manufacturer Narrative
E3: occupation: supply chain director.The actual sample was received.The proximal end and distal end of the broken catheter were received.Both ends of the tube were cut unevenly, slightly elongated, and pressed.The tube of the distal end was deformed and there was a clip mark observed.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.All samples met the required specifications.There was no issued nonconformity report related to human error during lot production.The reported item code is produced at sr4, 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 condition.The catheter tube and catheter hub fitting test is conducted during the production process.The records showed that the results were passed.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 undergoes 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, we received a total of 19 out of 31 (58%) complaints for the same issue that have occurred during usage.The result of the investigation showed that there was no attributable cause noted related to our product or the manufacturing process.Based on the results of our investigation, the cause cannot be identified to be related to our product or manufacturing process.The proximal portion and distal portion of the actual sample were evaluated.The appearance of the catheter tube indicates that it was most likely clipped and pulled, causing it to break.As informed through the details of the complaint, the involved device was inserted and placed on the patient for two days without any reported issues which indicates that the device was successfully inserted.The damage likely occurred during the removal process.The catheter tube condition of our retention samples was visually good and passed the related functional tests.The lot history file was checked, and no nonconformity was noted that may result in catheter tube breakage.The broken catheter tube was found during the removal process indicating that the device was successfully inserted.Our catheter tube has high tensile strength and does not break easily even when a strong force is applied.There is no evidence that there was a pre-existing defect with the device related to either the materials or the manufacturing process.A review of the product's lot history file revealed no issues that were encountered during the production of the reported lot.We have routine inspections to check the condition of the products, and we hope we have cleared up this quality matter with you.We perform 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 (b)(4) (philippines) corporation (manufacturer) registration no.(b)(4).Please refer to section h10 for the importer's report on the reported event.
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
• 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: 21980043
• Report Number: 3003902955-2025-00018
• Device Sequence Number: 9095743
• 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
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2022
• 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
• Patient Sex: Unknown