BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS INC CATHETER 15CM SCHON XL

    MDR report key: 15589021 · Received October 11, 2022

    Report

    Report Number
    MW5112554
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    October 4, 2022
    Report Date
    October 7, 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

    VASCATH PLACEMENT, UPON FLUSHING CATHETER A HOLE WAS NOTED IN CLEAR TUBING ON BLUE PORT. VASCATH EXCHANGED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2803823 ANGIODYNAMICS INC CATHETER 15CM SCHON XL CATHETER, HEMODIALYSIS, IMPLANTED MSD ANGIODYNAMICS INC. MQFK510

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male