BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX INFECTION CONTROL 400 SERIES TEMP-SENSING FOLEY CATHE

    MDR report key: 2900923 · Received November 30, 2012

    Report

    Report Number
    2900923
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 10, 2012
    Report Date
    November 21, 2012
    Manufacturer
    C.R. BARD, INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A FOLEY CATHETER INSERTED EARLY A.M. WITH SOME URINE OUTPUT RECORDED DURING THE FIRST FEW HOURS OF PLACEMENT. LATER THE NURSE NOTED THAT THE PATIENT HAD A DISTENDED ABDOMEN. THE PATIENT HAD NO URINE OUTPUT IN THE FOLEY CATHETER. PATIENT'S BLOOD PRESSURE/PULSE HAD ELEVATED. THE PATIENT'S BLADDER WAS SCANNED FOR > 999 ML. A NEW FOLEY WAS PLACED FOR AN IMMEDIATE RETURN OF 1200 ML CLEAR YELLOW URINE. THE PATIENT'S VITAL SIGNS WERE STABILIZED AND THE PATIENT'S ABDOMEN WAS SOFT AND NON-DISTENDED. NO VISIBLE DEFECTS WERE NOTED IN THE FOLEY CATHETER AND IT WAS NOT SAVED. NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDEX INFECTION CONTROL 400 SERIES TEMP-SENSING FOLEY CATHE CATHETER KOD C.R. BARD, INC. * FY2224

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR