BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TR BAND

    MDR report key: 24784264 · Received April 3, 2026

    Report

    Report Number
    1118880-2026-00125
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 3, 2026
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DXC
    PMA / PMN Number
    K152525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TR BAND AND PACKAGING LABEL WERE RETURNED TO TERUMO MEDICAL CORPORATION FOR ASSESSMENT. THE SAMPLE WAS SUBJECTED TO VISUAL ANALYSIS. NO DAMAGE OR DEFORMITIES WERE NOTED ON THE BAND OR BALLOON ASSEMBLY. THERE IS 6ML OF AIR LEFT IN THE BAND. 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. AIR BUBBLES WERE OBSERVED FROM THE CHECK VALVE. THE SAMPLE FAILED LEAK TESTING. THE CHECK VALVE WAS DECONSTRUCTED TO CHECK FOR DAMAGE OR FOREIGN MATTER. UPON DECONSTRUCTION, PIECES OF FOREIGN MATTER WERE FOUND. ONE TR BAND AND PACKAGING LABEL WERE RETURNED FOR ASSESSMENT AND THE SAMPLE LEAKED AT THE CHECK VALVE DUE TO FOREIGN MATTER. THE COMPLAINT CAN BE CONFIRMED FOR AIR LEAKAGE ISSUES. THE CAUSE IS FOREIGN MATTER IN THE CHECK VALVE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH TERUMO MEDICAL CORPORATION SPECIFICATIONS AND PROCEDURES. A CORRECTIVE ACTION WAS INITIATED FOR THIS ISSUE.

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBER: REQUESTED, UNKNOWN. D4: EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. D4: UDI: UNKNOWN DUE TO UNKNOWN LOT NUMBER. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: CATH LAB INVENTORY COORDINATOR. H4: DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE TR BAND LOST PRESSURE WHILE IN USE IN THE CARDIOVASCULAR CARE UNIT (CVCU) POST PROCEDURE WITH ACTIVE BLEEDING OCCURRING AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125388 TR BAND CLAMP, VASCULAR DXC TERUMO MEDICAL CORPORATION TRB24-REG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown