BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO DYNAMICS DRAIN CATHETER, 10FR APD

    MDR report key: 10634409 · Received October 5, 2020

    Report

    Report Number
    MW5097082
    Event Type
    Injury
    Date Received
    October 5, 2020
    Date of Event
    September 11, 2020
    Report Date
    October 1, 2020
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CATHETER BROKE INSIDE OF PATIENT SPONTANEOUSLY. ANGIO DYNAMICS GENERAL DRAINAGE CATH OCKING PIGTAIL 10 FR. 30 CM. ON (B)(6) 2020 PIGTAIL REMOVED. PRODUCT 10FR APD DRAIN LOT 5553379, PRODUCT #14000804, ANGIODYNAMICS REP WAS NOTIFIED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090084 ANGIO DYNAMICS DRAIN CATHETER, 10FR APD CATHETER, IRRIGATION GBX ANGIODYNAMICS, INC. 14000804 5553379

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention