BEUDAMED
    FDA Adverse Event Other Summary report: N

    GROSHONG PICC

    MDR report key: 709420 · Received April 19, 2006

    Report

    Report Number
    MW1038750
    Event Type
    Other
    Date Received
    April 19, 2006
    Date of Event
    April 4, 2006
    Report Date
    April 19, 2006
    Manufacturer
    BARD ACCESS SYSTEMS, INC
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INSERTED PICC LINE IN LEFT MEDIAN ANTECUBITAL VEIN ON AN OUTPATIENT MEDICAL, AFTER COMPLETION OF ATB DRESSING WAS CHANGED AS INITIAL DRSG WAS SATURATED WITH BLOOD FROM PROCEDURE. WHEN NURSE WENT TO REMOVE THE STERISTRIP THAT WAS CHEVRONED THE PICC LINE BROKE COMPLETELY IN TWO. LINE WAS REMOVED FROM THE PT. THE PT THEN NEEDED TO HAVE LINE REPLACED PRIOR TO THE NEXT DOSE OF ATB. THE SAME LOT NUMBER OF PICC WAS USED ON A PREVIOUS PT AND THAT PT HAD A CRACK DEVELOP IN THE SAME OR NEAR SAME PLACE ON THE CATHETHER. THE SITE WHERE THE CATHETER BROKE INTO TWO PIECES WAS PROXIMAL TO THE CONNECTOR HUB THE SAME SITE WHERE A CRACK DEVELOPED IN THE PREVIOUS 2 PICC LINES USED ON THE PRIOR PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG PICC 5FR D/L LJS BARD ACCESS SYSTEMS, INC * REPJ0785

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other