BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERASE CAUTI

    MDR report key: 3590800 · Received November 26, 2013

    Report

    Report Number
    3590800
    Event Type
    Malfunction
    Date Received
    November 26, 2013
    Date of Event
    November 25, 2013
    Report Date
    November 26, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLEY WILL NOT DEFLATE.====================== MANUFACTURER RESPONSE FOR FOLEY CATHETER, MEDLINE (PER SITE REPORTER).======================1. IT SOUNDS TO HIM AS IF THE INFLATION VALVE IS NOT ENGAGING, SO HE ASKED THAT THEY REALLY PUSH THE SYRINGE (OR PULL ANOTHER SYRINGE) INTO THE VALVE TO ENSURE THAT ITS ENGAGING PROPERLY. ONCE THEY DO THIS AND GET THE VALVE TO ENGAGE, THEN ALLOW THE BALLOON TO PASSIVELY DEFLATE.2. IF THAT DOESN'T WORK, CUT THE CATHETER JUST ABOVE THE INFLATION VALVE, LIKE RIGHT WHERE THE SHRINK WRAP IS AROUND THE VALVE. SEE IF IT DRAINS, AND IF IT DOESN'T, ATTACH A SYRINGE TO THE OPENING AND PULL BACK. 3. IF THAT DOESN'T WORK, CUT THE INFLATION LUMEN RIGHT BY THE Y-JUNCTION. YOU'LL SEE TWO LUMENS, THE SMALLER ONE IS THE INFLATION LUMEN. USE A 16 OR 18 GAUGE NEEDLE IN THE SMALL LUMEN AND A SYRINGE AT THE END TO SUCK THE WATER OUT OF THE BALLOON. THIS CAN BE DONE AT THE BEDSIDE.4. IF ALL OF THE ABOVE DO NOT WORK, ITS LIKELY NECESSARY TO CALL THE UROLOGIST.5. USE A GUIDE WIRE TO GO UP INTO THE INFLATION LUMEN AND POP THE BALLOON. THIS CAN BE DONE AT THE BEDSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617627 ERASE CAUTI FOLEY CATHETER NWR MEDLINE INDUSTRIES, INC. * QUKP

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR