MAUDE Adverse Event Report: Terumo Medical Corporation (TMC) TR BAND; CLAMP, VASCULAR

Model Number	TRB24-REG-01
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo received the following reported information: the original band was tested after it was removed from the patient, inserted 15cc of air and then removed the air later and only 13cc were left.It seemed the device was leaking air.Following replacement, no further signs of bleeding or hematoma were observed.No blood loss was reported.The product was stored within expectations.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the complete investigation results.This reported event has been reassessed and deemed not reportable based upon the investigation of the actual sample.One tr band, inflator, and packaging label were returned for assessment.The sample was subjected to visual analysis.No damage or deformities were observed on the band or inflator.The sample was subjected to leak testing.Approximately 18ml of air was injected into the band and submerged in a water bath for 30 seconds.No air bubbles were observed from the inflation port or balloon assembly.The sample passed leak testing.The check valve was deconstructed to check for damage or foreign matter.Upon deconstruction, foreign matter was found.One tr band, inflator, and packaging label were returned for assessment and the sample passed leak testing.The check valve was deconstructed and foreign matter was found.The complaint can be confirmed for foreign matter in the check valve.Review of the device history record showed there were no issues noted during the manufacture of the product that could have contributed to this complaint condition.A corrective action was initiated for this issue.

• Brand Name: TR BAND
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): Terumo Medical Corporation (TMC); 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): Terumo Medical Corpotation; 950 elkton blvd; elkton MD 21921
• Manufacturer Contact: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; +1(949)989-0491
• MDR Report Key: 50519486
• Report Number: 1118880-2026-00610
• Device Sequence Number: 21506206
• Product Code: DXC
• UDI-Device Identifier: 00389701012469
• UDI-Public: (01)00389701012469(17)280401(10)0001395867
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K213531
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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: TRB24-REG-01
• Device Catalogue Number: TRB24-REG-01
• Device Lot Number: 0001395867
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2025
• 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: 73 YR
• Patient Sex: Male