BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MORPHEUS

    MDR report key: 2842783 · Received October 4, 2012

    Report

    Report Number
    2842783
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    August 23, 2012
    Report Date
    October 4, 2012
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ON A ROUTINE ASSESSMENT, THE BEDSIDE NURSE OBSERVED THAT THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE TUBING WAS CRACKED AT THE JUNCTION BETWEEN THE TUBING AND THE PORT CAP. THE LINE WAS CHANGED. THERE WAS NO HARM TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MORPHEUS CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 LJS ANGIODYNAMICS, INC. * 577018

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR NO OTHER THERAPIES