BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFEPORT INFUSION SET WITH Y-SITE

    MDR report key: 2426261 · Received January 17, 2012

    Report

    Report Number
    1056436-2012-00005
    Event Type
    Other
    Date Received
    January 17, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 17, 2012
    Manufacturer
    ANGIODYNAMICS
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE HUBER NEEDLE IS PRIMED WITH NORMAL SALINE PRIOR TO INSERTION NO LEAKAGE NOTED. THE PT IS THEN STARTED ON THE THERAPY AND ANYWHERE FROM 12-24-48 HOURS THE DEVICE IS FOUND LEAKING. THIS IS A HIGH RISK OF AIR ENTRY, POTENTIAL FOR INFECTION AND DANGER TO MEDICAL STAFF AS OFTEN IT IS CHEMOTHERAPY AGENTS THAT ARE INFUSING. THIS IS NOT A NEW PROBLEM WITH THIS NEEDLE IT HAS HAPPENED MANY TIMES BEFORE. THE MAIN LEAKAGE IS FOUND AT THE HUB OF THE CATHETER AND THE CONNECTION WHERE THE NEEDLE JOINTS THE BODY OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT INFUSION SET WITH Y-SITE INFUSION SETS FPA ANGIODYNAMICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1