BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3 FR GROSHONG PICC BASIC TRAY

    MDR report key: 1242929 · Received November 21, 2008

    Report

    Report Number
    3006260740-2008-00215
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 21, 2008
    Report Date
    November 6, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K926331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME FOR EVALUATION. A CHR REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    THE CATHETER BROKE DURING REMOVAL WHEN THE USER FELT RESISTANCE AND PULLED THE CATHETER. THE BREAK SITE WAS LOCATED NEAR THE CATHETER INSERTION SITE. THE BROKEN CATHETER FRAGMENTS MIGRATED INTO THE CUBITAL VEIN TO THE SUPERIOR VENA CAVA, AND WERE REMOVED BY SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 FR GROSHONG PICC BASIC TRAY LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention