BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUBER PLUS

    MDR report key: 3232383 · Received July 8, 2013

    Report

    Report Number
    3232383
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 21, 2013
    Report Date
    July 8, 2013
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    DURING INSERTION OF THE HUBER NEEDLE, THE PATIENT COMPLAINED OF PAIN AND THE NEEDLE WAS DIFFICULT TO INSERT. NOTICED THAT THE TIP OF THE NEEDLE WAS BENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ACCESS A PORT-A-CATH.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308994 HUBER PLUS SET, ADMINISTRATION, HUBER NEEDLE FPA C.R. BARD, INC. * REXC1057

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR