BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MORPHEUS

    MDR report key: 4544776 · Received February 17, 2015

    Report

    Report Number
    4544776
    Event Type
    Malfunction
    Date Received
    February 17, 2015
    Date of Event
    December 1, 2014
    Report Date
    February 17, 2015
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    MULTIPLE EXAMPLES OF ANGIODYNAMIC PICC LINES PLACED IN INSTITUTION ON PATIENTS THAT ARE BEING DISCHARGED HOME, BUT CONTINUING TO RECIEVE PICC MEDICATION, FROM APPROXIMATELY NOV 2014 -DEC 2014, WERE REPORTED TO BE LEAKING, SLIPPAGE, OR OTHER PICC RELATED ISSUES. 5 OF THESE EXAMPLE OCCURRED AT THIS FACILITY BUT OTHER EXAMPLE HAVE OCCURRED WITHIN OUR HEALTH SYSTEM.PATIENT 1: SL PICC ¿ CALL FROM RN IN HOME PT PICC LINE CLAMP IS BROKEN AND HAS MIGRATED OUT 7CM. ORDER RECEIVED FROM MD TO PULL THE LINE.PATIENT 2:SL PICC - PT REPORTED TO THE ER; LINE IS LEAKING. PICC REPLACED BY IR.INDWELLING PICC LINE CRACKED AT HUB.PATIENT 3: THE PATIENT'S PREVIOUSLY PLACED PICC LINE IS LEAKING ATTHE HUB.PATIENT 4:SL PICC ¿ RN FROM HOME CALLED REPORTED LINE IS LEAKING FROM THE HUB. PICC REMOVEDPATIENT 5:DL PICC ¿ CALL FROM PT. LINE BROKE ABOVE THE RED LUMEN. THE RED LUMEN FELL OFF WITH A CLEAN BREAK PT CLAMPED THE LINE IMMEDIATELY. PT REFUSED TO GO TO THE ER. PER DR. JUST KEEP IT CLAMPED AND COVERED WITH GAUZE AND TAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114164 MORPHEUS CATHETER, INTRAVASCULAR LJS ANGIODYNAMICS, INC. * 4804331
    114165 MORPHEUS CATHETER, INTRAVASCULAR LJS ANGIODYNAMICS, INC * 4828114
    114166 MORPHEUS CATHETER, INTRAVASCULAR LJS ANGIODYNAMICS, INC * 4828114
    114167 MORPHEUS CATHETER, INTRAVASCULAR LJS ANGIODYNAMICS, INC. * 4804330
    114168 MORPHEUS CATHETER, INTRAVASCULAR LJS ANGIODYNAMICS, INC * 4774765

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR
    2 37 YR
    3 15 YR
    4 23 YR
    5 65 YR