BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX FOLEY CATHETER

    MDR report key: 5056515 · Received September 4, 2015

    Report

    Report Number
    5056515
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    May 6, 2015
    Report Date
    July 30, 2015
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    EZC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLEY CATHETER WAS INSERTED AND INITIALLY DRAINED 25 ML, BUT THEN STOPPED DRAINING. A BLADDER SCAN SHOWED THAT HE HAD 600 ML OF URINE IN THE BLADDER. NURSE ATTEMPTED TO DEFLATE THE BALLOON TO REMOVE THE CATHETER, BUT THE BALLOON WOULD NOT DEFLATE. A UROLOGIST WAS CONSULTED AND HE INSTILLED 3 ML OF MINERAL OIL INTO THE BALLOON AND AFTER SEVERAL MINUTES THE BALLOON RUPTURED AND THE CATHETER CAME OUT. HE HAD PLANNED TO DO A CYSTO AFTER THE PATIENT WAS STABILIZED TO DETERMINE IF THERE WERE ANY RETAINED PIECES OF THE BALLOON IN THE BLADDER BUT THE PATIENT EXPIRED AND THIS WAS NOT DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586891 BARDEX FOLEY CATHETER CATHETER, COUDE EZC BARD MEDICAL DIVISION 0168L16

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR