BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 2132602 · Received June 10, 2011

    Report

    Report Number
    MW5020984
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 3, 2011
    Report Date
    June 10, 2011
    Manufacturer
    BARD
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE HAVE HAD 3 PTS WITH OCCLUSION ISSUES RELATED TO AN 4 FR PICC OVER THE LAST FEW WEEKS. THESE ISSUES OCCURRED SHORTLY AFTER INSERTION AND 2 OF THEM RESULTED IN A NEW PICC BEING INSERTED. WHEN THE 2 PICCS WERE REPLACED THEY WERE INSPECTED FOR OCCLUSION AND FLUSHED WITH SALINE. ALL OF THE PICCS FLUSHED WITH NO RESISTANCE WHATSOEVER. OF NOTE, ALL OF THESE ISSUES HAVE BEEN WITH THE 4 FR PICC'S IN THE SAPIENS INSERTION KIT AND WITH THE SAME LOT NUMBER -REVA1229-. THERE HAVE BEEN NO ISSUES WITH ANY OF THE OTHER LOT NUMBERS, SO HOPEFULLY THIS IS CONTAINED TO THIS SPECIFIC LOT NUMBER. WE HAVE A PICC THAT BARD HAS TAKEN FOR TESTING AND THEY WILL ALSO TEST OTHER PICCS FROM WITHIN THE LOT NUMBER POTENTIALLY EFFECTED. BARD IS ALSO PLANNING TO REPLACE OUR CURRENT SUPPLY OF 4 FR PICCS WITH ANOTHER LOT NUMBER. ALL OF THESE PICCS HAVE BEEN PULLED FROM CIRCULATION SO THE PICC TEAM IS NO LONGER PLACING ANY OF THESE PICCS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD 4 FR PICC IN SAPIENS INSERTION KIT LJS BARD REVA1229

    Patients

    Seq Age Sex Outcome Treatment
    1