BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX

    MDR report key: 3944605 · Received July 14, 2014

    Report

    Report Number
    MW5037283
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    April 30, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BARDEX
    Product Code
    MJC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BARDEX URINARY CATHETER WAS TO BE REMOVED AND BULB WOULD NOT DEFLATE. UROLOGIST COULD NOT COME TO SEE PT TIL THE FOLLOWING DAY, BUT ADVISED THE PCP TO PUT MORE SALINE IN THE BULB. RESISTANCE WAS MET AND NO ADDITIONAL SALINE WAS ADDED. THE UROLOGIST SUGGESTED THE TUBING TO THE BULB BE CUT AND ALLOW THE SALINE TO DRAIN OUT OF THE BULB, BUT THE PCP WAS NOT COMFORTABLE WITH THIS. PT HAD TO STAY AN ADDITIONAL DAY TO WAIT FOR THE UROLOGIST TO REMOVE THE FOLEY WITH A GUIDEWIRE. IN THE MEAN TIME THE FOLEY FELL OUT DURING THE NIGHTSHIFT. DATES OF USE: (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: PT HAD ALTERED MENTAL STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410264 BARDEX FOLEY CATHETER MJC BARDEX 0165SI16 3HL9013

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention