BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONE TIP URETERAL CATHETER

    MDR report key: 1210823 · Received July 2, 2008

    Report

    Report Number
    1825146-2008-00024
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 3, 2008
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FAD
    PMA / PMN Number
    760858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED PACKAGE AS REC'D CONTAINING ONE USED CATHETER; THE CONE TIP WAS NOT RETURNED FOR EVAL. THE CUSTOMER WAS CONTACTED IN REGARD TO THE LOCATION OF THE CONE TIP. THE CUSTOMER HAS INDICATED THE CONE TIP PORTION WAS LEFT IN THE PT'S KIDNEY AND THE PHYSICIAN HAS NO INTENTION OF REMOVING THE TIP FROM THE PT; HOPING IT WOULD NOT CAUSE ANY HARM TO THE PT. EACH LOT OF CATHETERS ARE PULL TESTED PRIOR TO PACKAGING. SIX DIFFERENT LOT NUMBERS WERE PULLED FROM STOCK AND PULL TESTED. EACH LOT NUMBER WAS NOTED TO CONTAIN TEN CATHETERS. EACH CATHETER WAS PULLED TESTED AND NOTED TO SEPARATE ABOVE THE MINIMUM TENSILE REQUIREMENT FOR THIS PROD. INADEQUATE ROUGHENING ON THE TIP OF THE CATHETER HAS CAUSED THE CONE TIP TO SEPARATE FROM THE MAIN CATHETER SHAFT CAUSING THE CUSTOMER'S DIFFICULTY. THE PROPER INDIVIDUALS HAVE BEEN NOTIFIED OF THIS OCCURRENCE.

    Description of Event or Problem · 1

    CUSTOMER STATES: "THE DR WAS USING THE CATHETER AND THE TIP SEPARATED FROM THE CATHETER, LEAVING THE TIP IN THE RENAL PELVIS OF THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONE TIP URETERAL CATHETER KOD URETERAL CATHETERS AND ACCESSORIES FAD COOK UROLOGICAL, INC. NA U1699321

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention