BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA PICC

    MDR report key: 2026737 · Received March 16, 2011

    Report

    Report Number
    MW5019864
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    NAVILYST MEDICAL, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DUAL LUMEN PICC PLACED BY PICC TEAM (B)(6) 2011. PURPLE LUMEN OCCLUDED, UNABLE TO FLUSH OR INFUSE. ORANGE LUMEN FLUSHES BUT HAS A PUNCTURE HOLE IN THE EXTERNAL PORTION. WHILE LINE IS BEING FLUSHED, A STEADY STREAM SPRAYS OUT OF PUNCTURE HOLE IN TUBING OF OUTER PICC LUMEN. POSSIBLE TAMPERED WITH BY PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCELA PICC DUAL LUMEN PICC FOZ NAVILYST MEDICAL, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR