BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 2082508 · Received April 29, 2011

    Report

    Report Number
    2082508
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 29, 2011
    Manufacturer
    B. BRAUN
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    IV CATHETER BENT, POSSIBLE NEEDLE PUNCHING CATHETER. TRIED TO START IV, INSERTED/STARTED TO ADVANCE, BUT IT WOULD NOT ADVANCE. PULLED OUT AND SAW CATHETER WAS BENT. UPON LOOKING AT THE BENT CATHETER, THOUGHT I SAW A HOLE IN THE CATHETER WHERE NEEDLE ADVANCED OUT. THIS IS THE 2ND RN THIS HAS OCURRED WITH. ALSO, THESE ARE THE SAME ANGIOS THAT DR IS COMPLAINING ABOUT KINKING WHEN STATLOCKS ARE APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY SAFETY IV CATHETER FOZ B. BRAUN * 0L25258318

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR