BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD URETERAL STENT

    MDR report key: 1934159 · Received December 8, 2010

    Report

    Report Number
    1018233-2010-00153
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FAD
    PMA / PMN Number
    K983498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED FOR EVALUATION FINDING A CLEAN CUT IN THE KIDNEY PIGTAIL PORTION OF THE STENT. THE CLEAN CUT APPEARS TO HAVE BEEN MADE WITH A SHARP INSTRUMENT. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE LOT NUMBER PROVIDED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IN ADDITION, THE MANUFACTURING PROCESS FOR THIS PRODUCT CODE SHOWED THAT THIS STENT IS RECEIVED FROM A SUPPLIER WHO PROVIDES CERTIFICATION THAT THE STENT HAS BEEN MANUFACTURED, INSPECTED, AND ACCEPTED ACCORDING TO THE SPECIFICATIONS PROVIDED BY THE MANUFACTURER. AS A FINISHED GOOD, QUALITY ASSURANCE PERFORMS RANDOM VISUAL INSPECTIONS TO ASSURE THAT ALL COMPONENTS ARE PRESENT AND CORRECT. A REVIEW OF INTERNAL REJECT RECORDS SHOWED NO REJECTIONS RESULTED FROM THE VISUAL INSPECTIONS OVER THE LAST TWO YEARS. THE INSTRUCTIONS FOR USE STATES IN THE PRECAUTIONS SECTION, THE FOLLOWING: "DO NOT USE IF THE PACKAGE OR PRODUCT IS DAMAGED. EXERCISE CARE. TEARING OF THE STENT CAN BE CAUSED BY SHARP INSTRUMENTS. CARE SHOULD BE EXERCISED WHEN REMOVING THE STENT FROM INNER POLYBAG SO AS NOT TO CAUSE TEARING OR FRAGMENTATION." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STENT WAS FOUND IN TWO PIECES WHEN THE PACKAGE WAS OPENED. THE SUTURE WAS STILL ATTACHED AND IT HAD A SMOOTH, CLEAN CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD URETERAL STENT FAD C.R. BARD, INC. NA NGUH1312

    Patients

    Seq Age Sex Outcome Treatment
    1 NA