BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD PRIMARY IV SET

    MDR report key: 235361 · Received August 6, 1999

    Report

    Report Number
    MW1016901
    Event Type
    Malfunction
    Date Received
    August 6, 1999
    Date of Event
    July 28, 1999
    Report Date
    August 6, 1999
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SEVERAL NURSES HAVE STUCK THEMSELVES WITH THESE NEW SETS (WITH LONGER SPIKE) WHILE SPIKING THE BAG. THIS IS NOT A CONTAMINATED WOUND, BUT NECESSITATES CHANGING THE BAG WHICH WAS PERFORATED AND THE TUBING SET, DELAYING CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD PRIMARY IV SET IV TUBING FPA ABBOTT LABORATORIES 11309 52-149 NS

    Patients

    Seq Age Sex Outcome Treatment
    1 *