BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN-END URETERAL CATHETER

    MDR report key: 2091179 · Received May 10, 2011

    Report

    Report Number
    1825146-2011-00024
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    March 25, 2011
    Report Date
    May 3, 2011
    Manufacturer
    COOK UROLOGICAL INC.
    Product Code
    GBL
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A PORTION OF THE CATHETER WAS RETURNED IN A BIOHAZARD BAG ALONG WITH THE LABEL. THE CATHETER PORTION RETURNED WAS THE BACKEND MEASURING 51.1CM NOTING THE TOUHY-BORST ADAPTER WAS STILL ATTACHED, THE REMAINDER OF THE CATHETER, APPROXIMATELY 20CM WAS NOT RETURNED. IN VIEWING THE END OF SEPARATION, IT WAS NOTED TO HAVE A PINCHED APPEARANCE NOTING THE CATHETER HAS BEEN PARTIALLY CUT AND THEN PULLED TO SEPARATION. MOST LIKELY THE DEVICE HAS BEEN DAMAGED BY AN INSTRUMENT OF UNDETERMINED ORIGIN. NOTHING HAD TO BE RETRIEVED FROM THE PATIENT, ALL PIECES OF THE CATHETER WERE STATED TO BE INSIDE THE SCOPE, HOWEVER, THE CUSTOMER WILL BE CONTACTED TO ADDRESS THE LOCATION OF THE REMAINING PIECES. SHOULD ADDITIONAL INFORMATION BE RECEIVED IT WILL BE FORWARDED.

    Description of Event or Problem · 1

    AS STATED ON THE MEDWATCH REPORT: A COOK 5FR OPEN END CATHETER BROKE INTO 3 PIECES WHILE IN USE. THE PIECES BROKE WHILE STILL INSIDE THE SCOPE; NO PIECES WERE LOOSE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPEN-END URETERAL CATHETER GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY GBL COOK UROLOGICAL INC. NA U2027529

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR