BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD URETERAL CATHETER

    MDR report key: 1062661 · Received June 12, 2008

    Report

    Report Number
    1018233-2008-00043
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 15, 2008
    Report Date
    June 12, 2008
    Manufacturer
    C.R. BARD, INC.
    Product Code
    EYB
    PMA / PMN Number
    PRE-AMEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE MANUFACTURING LOT NUMBER PROVIDED, PRODUCT IS IN EXCESS OF 34 YEARS OLD. WHILE THE POLYURETHANE DEVICE IS VERY DURABLE, SOME DEGRADATION OF PRODUCT INTEGRITY IS EXPECTED OVER A 34 YEAR PERIOD. A 5 YEAR EXP DATE WAS PLACED ON THESE PRODUCTS IN THE EARLY NINETIES. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE SAMPLE EVAL. BASELINE REPORT PREVIOUSLY PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE URETERAL CATHETER BROKE INTO MULTIPLE PIECES DURING A DIAGNOSTIC URETEROSCOPY. THE PIECES OF THE CATHETER THAT ARE IN THE URETER HAVE NOT BEEN REMOVED, AND WILL BE REMOVED IN APPROX 6 WEEKS VIA URETEROSCOPY. THE CATHETER WAS BEING USED DURING AN OPEN PROSTATECTOMY PROCEDURE, SO THAT THE DOCTOR COULD VISUALIZE THE URETER DURING THE PROCEDURE. NO STONES WERE NOTED IN THE PT. THE DOCTOR STATED THAT THE CATHETER BROKE IN THE DISTAL URETER AND PROBABLY BROKE IN ANOTHER LOCATION IN THE URETER. NO IMPACT TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD URETERAL CATHETER EYB C.R. BARD, INC. NA AL31521

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK