BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAUN

    MDR report key: 1190206 · Received October 6, 2008

    Report

    Report Number
    MW5008547
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 6, 2008
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PT IS ONE OF SEVERAL PEDIATRIC/NICU PTS WHO HAVE EXPERIENCED A BROKEN FILTER TUBING NECESSITATING REPLACEMENT WHILE TUBING IS IN USE; IN THIS CASE MINOR BLEEDING THRU THE TUBING OCCURRED BUT WAS DISCOVERED PROMPTLY. ALL INVOLVE THE SAME PRODUCT. THERE HAVE BEEN NO SERIOUS EFFECTS BUT WE HAVE PULLED TUBING WITH A COMMON LOT NUMBER AFTER DISCUSSING WITH THE VENDOR REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAUN SMALL BORE FILTERED EXTENSION SET FPA 60987804

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability