BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT WITH MICRO

    MDR report key: 2040280 · Received February 15, 2011

    Report

    Report Number
    3006260740-2011-00077
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 5, 2011
    Report Date
    February 21, 2011
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A LEAK IN THE CATHETER IS CONFIRMED. RETURNED FOR EVAL IS AN ASSEMBLED 4 FR GROSHONG CATHETER. DURING FUNCTIONAL TESTING A LEAK WAS OBSERVED EMANATING FROM THE CATHETER JUST PROXIMAL TO THE 34 CM DEPTH MARKER. THE LEAK SITE IS < 0.2 INCHES IN LENGTH. THE SLIT EDGES ARE SHARP. THE TUBING SURROUNDING THE LEAK SITE IS UNREMARKABLE. APPLYING TENSION CAUSED THE EDGES TO GAPE AND REVEALS SMOOTH WALLS. THE DEPTH OF THE EDGE WALLS IS UNIFORM THROUGHOUT THE CIRCUMFERENCE OF THE SLIT. HOWEVER, AT THIS TIME THE MECHANISM OF DAMAGE IS UNDETERMINED. GROSS VISUAL, MICROSCOPIC AND FUNCTIONAL TESTING SHOWS NO EVIDENCE OF A DETECT OR DEFORMITY RELATED TO THE MFG PROCESS. A CHR IS NOT POSSIBLE, AS NO MFG LOT NUMBER INFO HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN NOTICED A LEAKAGE/EXTRAVASATION OF THE SOLUTION USED FOR PT INFUSION AT THE END OF THE CATHETER. THEREFORE, THE DEVICE WAS REMOVED AND THE PHYSICIAN NOTICED A SPLIT ON THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT WITH MICRO LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention