BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLASSIC ADULT COILED PD CATHETER

    MDR report key: 2061781 · Received April 13, 2011

    Report

    Report Number
    MW5020281
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    June 1, 2010
    Report Date
    April 13, 2011
    Manufacturer
    MEDIGROUP, INC
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PD CATHETER HAD A PIN SIZE HOLE ON "PT END" BEFORE ADAPTER. REQUIRED REPLACEMENT OF LINE AND NEW ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLASSIC ADULT COILED PD CATHETER PD CATHETER KDJ MEDIGROUP, INC CF 5260

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR