BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROVIAC

    MDR report key: 3110471 · Received May 6, 2013

    Report

    Report Number
    3110471
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    C. R. BARD, INC
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    2.7 BROVIAC WAS OPENED TO THE STERILE FIELD. O.R. TECHNICIAN TRIED TO FLUSH BROVIAC PRIOR TO USE BUT WAS UNABLE TO FLUSH. ATTENDING SURGEON WAS ABLE TO FLUSH WITH DIFFICULTY. BROVIAC WAS PLACED. ATTENDING SURGEON WAS UNABLE TO DRAW BACK BLOOD OR FLUSH. X-RAY WAS TAKEN TO CHECK FOR PLACEMENT, WHICH SHOWED GOOD PLACEMENT. BROVIAC REMOVED AND NEW BROVIAC PLACED WITH GOOD BLOOD RETURN AND ABLE TO FLUSH SUCCESSFULLY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CVL INSERTION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197379 BROVIAC CATHETER KOD C. R. BARD, INC * REWL1227

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DAY NO OTHER THERAPIES