BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER LOC

    MDR report key: 3202303 · Received June 25, 2013

    Report

    Report Number
    MW5030718
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BARD
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, RN WAS PUSHING ADRIAMYCIN (DRUG IS RED, CHEMOTHERAPY) PER MEDIPORT WITH FREE FLOWING NORMAL SALINE IV. PT HAD A GAUZE DRESSING OVER HUBER NEEDLE. NOTED NEW, RED DRAINAGE ON DRESSING. DRESSING REMOVED. SLOWLY PUSHED ADDITIONAL ADRIAMYCIN, AND SAW ADRIAMYCIN BUBBLING UP FROM HUBER NEEDLE AT THE 90 DEGREE BEND IN THE NEEDLE. PRESENT HUBER NEEDLE PULLED. NEW HUBER NEEDLE PLACED WITHOUT FURTHER LEAKING. NO ADRIAMYCIN CAME IN CONTACT WITH THE PT'S SKIN. NO HARM CAUSED TO PT. HAD THREE OTHER EPISODES WITH BLOOD DRAWS FROM HUBER NEEDLE WHERE BLOOD WAS BUBBLING OUT FROM THE 90 DEGREE BEND, AND LAB DRAW WAS FROTHY WITH AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288029 POWER LOC POWER LOC FOZ BARD ASXDS115

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR