BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS INC CATHETER DIALYSIS SCHON XL ACUTE

    MDR report key: 13847181 · Received March 21, 2022

    Report

    Report Number
    MW5108378
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    March 17, 2022
    Report Date
    March 18, 2022
    Manufacturer
    ANGIODYNAMICS INC.
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CATHETER PULLING IN AIR IN DIALYSIS; FLUSHED AND WETNESS HAPPENED ON PT. LEG; PRODUCT REMOVED AND HOLE IN CLEAR CATHETER FROM BLUE PORT SIDE. FDA SAFETY REPORT ID#:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879241 ANGIODYNAMICS INC CATHETER DIALYSIS SCHON XL ACUTE CATHETER, HEMODIALYSIS, IMPLANTED MSD ANGIODYNAMICS INC. MPWG110

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female