BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD

    MDR report key: 3944673 · Received July 11, 2014

    Report

    Report Number
    MW5037295
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 11, 2014
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON ACCESSING THE PT WITH THE POWERLOC NEEDLE, THE PT VERBALIZED THAT HE FELT FLUID DRIPPING DOWN HIS NECK. THE RN ASSESSED THE NEEDLE TO FIND THE NEEDLE LEAKING AT THE BAND WHERE THE PLASTIC MEETS THE METAL. THE PT HAD TO BE RE-ACCESSED FOR CHEMOTHERAPY, BUT THERE WAS NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406947 BARD POWERLOC NEEDLE FPA ASYDS101

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other