BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARBURST SEMI-FLEX, 25CM

    MDR report key: 2484823 · Received March 6, 2012

    Report

    Report Number
    1056436-2012-00021
    Event Type
    Other
    Date Received
    March 6, 2012
    Date of Event
    February 23, 2012
    Report Date
    March 6, 2012
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE BLACK OUTER LAYER OF THE NEEDLE WAS TORE OUT AND THERE HAS BEEN A BLOOD LEAK FROM IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST SEMI-FLEX, 25CM RFA PROBE GEI ANGIODYNAMICS NA 540024

    Patients

    Seq Age Sex Outcome Treatment
    1