BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD

    MDR report key: 2575634 · Received May 9, 2012

    Report

    Report Number
    MW5025375
    Event Type
    Malfunction
    Date Received
    May 9, 2012
    Date of Event
    April 27, 2012
    Report Date
    May 9, 2012
    Manufacturer
    BARD MEDICAL DIVISION
    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

    PT WITH BLOOD TRANSFUSION INFUSION THROUGH POWERLOC PORT NEEDLE. RN NOTED BLOOD WAS LEAKING OUT OF THE YELLOW WING FROM A SMALL HOLE. NEEDLE CHANGED AND TRANSFUSION CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD POWERLOC PORT NEEDLE FPA BARD MEDICAL DIVISION 20 GAUGE POWERLOC ASWBS097

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR