BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT

    MDR report key: 2040307 · Received February 15, 2011

    Report

    Report Number
    3006260740-2011-00076
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 10, 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
    CH
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A LEAK IN THE CATHETER IS CONFIRMED. GROSS AND MICROSCOPIC EXAMINATIONS OF THE COMPLAINT SAMPLE REVEALED THREE PARTIAL TEARS IN THE CATHETER TUBING. THE PARTIAL TEARS IN THE TUBING ARE LOCATED BETWEEN THE 29 AND 31 CM DEPTH MARKERS. THE TEARS ARE NEARLY PERPENDICULAR TO THE AXIS OF THE TUBING. THE TEAR SITE REVEALS ROUNDED EDGES AND THE TUBING SURROUNDING, THE PARTIAL TEAR SITES IS SLIGHTLY COMPRESSED. THIS COMBINED EVIDENCE OF THE IRREGULAR SLIT EDGES AND ROUGH, BROKEN SLIT WALLS IS TYPICAL OF MATERIAL FATIGUE AND FRICTION WEAR; HOWEVER, AT THIS TIME, THE EXACT MECHANISM OF DAMAGE IS UNDETERMINED. GROSS VISUAL, MICROSCOPIC AND FUNCTIONAL TESTING SHOWS NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MFG PROCESS. A CHR OF LOT# RETL0580 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PICC INSERTED WITH THE GUIDANCE OF SR5 FROM THE UPPER ARM, LEAKAGE APPEARED AND BEEN REPAIRED AFTER 2 MONTHS MAINTENANCE. AFTER ONE MONTH LATER, LIQUID LEAKED OUT AGAIN FROM THE INSERTION POINT. DURING THE FLUSHING AFTER PULLING OUT THE CATHETER, 3 HOLES WERE FOUND ON THE CATHETER BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT LJS C. R. BARD INC. (BASD) RETL0580

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention