BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA

    MDR report key: 4210123 · Received October 1, 2014

    Report

    Report Number
    2032582-2014-00006
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    May 19, 2013
    Report Date
    September 2, 2014
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    LJT
    PMA / PMN Number
    K073210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    XCELA POWER INJECTABLE PORT WAS EXPLANTED ON (B)(6) 2014. PRE AND POST IMAGES WERE OBTAINED. PATIENT NOTED HAD RAISED AREA UNDER INCISION LINE AFTER DISCHARGE. PATIENT RETURNED TO IR ON (B)(6) 2014. PLASTIC CONNECTOR WHICH CONNECTS THE CATHETER TO THE PORT WAS NOTED TO BE RETAINED IN THE PATIENT AND REMOVED. CONNECTOR IS RADIOTRANSPARENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613458 XCELA CATHETER, INTRAVASCULAR, THERAPEUTIC LJT PFM MEDICAL, INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention