BEUDAMED
    FDA Adverse Event Summary report: N

    BARDEX INFECTION CONTROL 400 SERIES TEMPERATURE-SENSING FOLE

    MDR report key: 2961373 · Received February 13, 2013

    Report

    Report Number
    2961373
    Date Received
    February 13, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 13, 2013
    Manufacturer
    C.R. BARD, INC.
    Product Code
    KOD
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NURSE NOTED THAT THE PATIENT'S URINE OUTPUT WAS DROPPING OFF AT THE START OF THE SHIFT WITH A TWO HOUR OUTPUT OF 27ML. THE NURSE REPORTED THE DECREASED URINE OUTPUT TO THE PHYSICIAN WHO ORDERED 20MG OF FUROSEMIDE IV WHICH WAS ADMINISTERED. TWO HOURS LATER THE NURSE NOTED THE PATIENT'S URINE OUTPUT AT 18ML. THE PATIENT'S BLADDER WAS SCANNED WITH READINGS 205-300ML. THE PHYSICIAN WAS INFORMED AND THE THERMISTOR CATHETER WAS REMOVED AND A NEW FOLEY CATHETER WAS INSERTED. THERE WAS IMMEDIATELY 230ML OUTPUT OF URINE. NO RELATED INJURY NOTED TO PATIENT. THE NURSE DID NOT INDICATE THERE WERE ANY VISUAL DEFECTS TO THE THERMISTOR CATHETER. THE TUBING PORTION-ONLY OF THE CATHETER WAS RETAINED AND AVAILABLE TO SHIP TO C.R. BARD FOR INSPECTION UPON THEIR REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64022 BARDEX INFECTION CONTROL 400 SERIES TEMPERATURE-SENSING FOLE CATHETER KOD C.R. BARD, INC. 129416M KR2204

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR