BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA

    MDR report key: 4008815 · Received June 19, 2014

    Report

    Report Number
    2032582-2014-00003
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 19, 2013
    Report Date
    June 19, 2014
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    LJT
    PMA / PMN Number
    K072481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE RESULT OF THE INVESTIGATION ON THE RETURNED PORT AND CATHETER, WE CONCLUDED THAT THE REPORTED DEFECT (SPLIT) IS DUE TO A PINCH-OFF GRADE 2 OF THE CATHETER.

    Description of Event or Problem · 1

    EVENT DESC: XCELA PORT SPLIT INSIDE IN THE PT, WAS PLACED ABOUT A MONTH AGO, HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360454 XCELA CATHETER, INTRAVASCULAR, THERAPEUTIC LJT PFM MEDICAL, INC 120841 000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention