BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCBAND

    MDR report key: 20611399 · Received November 4, 2024

    Report

    Report Number
    MW5162168
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Report Date
    October 31, 2024
    Manufacturer
    TELEFLEX LLC.
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    VASCBAND (PURPLE SYRINGE BAND) PLACED ON RIGHT WRIST POST HEART CATH (CATHETERIZATION). MD PLACED 14ML OF AIR IN VASCBAND. AT 1230, AIR WAS STARTED TO BE REMOVED USING THE PURPLE SYRINGE ON THE 2ML SETTING, EVERY 15 MINUTES. AT 1330, PATIENT WAS TO HAVE 6ML OF AIR LEFT, ATTEMPTED TO REMOVE 2 ML'S OF AIR, BUT ONLY ABLE TO REMOVE 1 ML OF AIR. BAND WAS MISSING 5ML'S OF AIR. NO BLEEDING OCCURRED. SITE WAS CLEAN, DRY, SOFT. NO HEMATOMA, NO BRUISING, NO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2133294 VASCBAND CLAMP, VASCULAR DXC TELEFLEX LLC. 202401913F8

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown