BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPARENT RADIAL ARTERY BAND

    MDR report key: 17186145 · Received June 21, 2023

    Report

    Report Number
    MW5118706
    Event Type
    Malfunction
    Date Received
    June 21, 2023
    Date of Event
    June 12, 2023
    Report Date
    June 16, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TRANSPARENT RADIAL ARTERY BAND WOULD NOT HOLD AIR WHEN APPLYING PRESSURE TO RADIAL ARTERY POST CARDIAC CATH. IT WAS LEAKING AT THE AIR LINE PART(DISTAL) ATTACHED TO THE TRANSPARENT RADIAL ARTERY BAND. NEEDED TO OPEN A NEW BAND AND RE-APPLY TO CONTROL BLEEDING. TRANSPARENT RADIAL ARTERY BAND TRB24-REG LOT#0000318689.

    Description of Event or Problem · 0

    TRANSPARENT RADIAL ARTERY BAND WOULD NOT HOLD AIR WHEN APPLYING PRESSURE TO RADIAL ARTERY POST CARDIAC CATH. IT WAS LEAKING AT THE AIR LINE PART(DISTAL) ATTACHED TO THE TRANSPARENT RADIAL ARTERY BAND. NEEDED TO OPEN A NEW BAND AND RE-APPLY TO CONTROL BLEEDING. TRANSPARENT RADIAL ARTERY BAND TRB24-REG LOT#0000318689.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221749 TRANSPARENT RADIAL ARTERY BAND CLAMP, VASCULAR DXC TERUMO MEDICAL CORPORATION TRB24-REG 0000318689

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female