BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER LOC

    MDR report key: 3840171 · Received May 23, 2014

    Report

    Report Number
    MW5036322
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    February 14, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BARD
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PORT-A-CATH ACCESSED WITH POWER LOC (HUBER NEEDLE) FLUSHED AND LEAKAGE OF IV FLUID NOTED AT BEND OF NEEDLE, REMOVED AND REPLACED WITH ANOTHER POWER LOC. HUBER NEEDLE USED TO ACCESS PORT-A-CATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307107 POWER LOC HUBER NEEDLE FPA BARD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other