BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROPHILLIC-COATED FOLEY CATHETER 5 CC BALLOON

    MDR report key: 2554567 · Received April 25, 2012

    Report

    Report Number
    MW5025199
    Event Type
    Injury
    Date Received
    April 25, 2012
    Date of Event
    March 30, 2012
    Report Date
    April 25, 2012
    Manufacturer
    C.R. BARD
    Product Code
    NWR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLEY CATHETER WAS INSERTED AT AROUND 10:05 AM WITHOUT DIFFICULTY. BALLOON WAS SLIGHTLY INFLATED AND DEFLATED WITH STERILE WATER. BALLOON WAS INTACT. CLEAR AMBER URINE WAS NOTED, BALLOON WAS INFLATED WITH 10 ML OF STERILE WATER. GEMZAR (CHEMO DRUG) WAS INSTILLED WITHOUT DIFFICULTY, TUBING WAS CLAMPED PER PROCEDURE. AROUND 10:40 AM, THERE WAS SOME SLIGHT LEAKING AROUND THE CATHETER. UNCLAMPED THE TUBING AND RELEASED SOME URINE INTO THE FOLEY BAG. RECLAMPED PER PROCEDURE AND LEAKING HAS NOW STOPPED. AROUND 10:45 AM, THE PT STATES HE FELT LIKE THE BALLOON BURST AND HEARD A LOUD POP. FOLEY WAS IMMEDIATELY REMOVED AND IN FACT THE BALLOON HAD BURST. THE PT IMMEDIATELY URINATED INTO THE URINAL WITHOUT DIFFICULTY. IT WAS NOTED THERE WAS SMALL OBJECT (POSSIBLE BALLOON) AT THE BOTTOM OF URINAL. AROUND 10:47, PHYSICIAN AT BEDSIDE AND ORDER, BEGIN TO ADMINISTER FLUIDS. PT WAS INSTRUCTED TO CONTACT UROLOGIST. UNFORTUNATELY THE UROLOGIST WAS OUT OF TOWN AND WAS ADVISED TO GO TO THE ED FOR FURTHER MONITORING AND EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROPHILLIC-COATED FOLEY CATHETER 5 CC BALLOON NWR C.R. BARD NGWA1089

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization