BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATEX FOLEY CATHETER, 16F

    MDR report key: 4194086 · Received October 14, 2014

    Report

    Report Number
    1417592-2014-00093
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 9, 2014
    Report Date
    October 6, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A GYNE PROCEDURE, AFTER THE FOLEY CATHETER WAS INSERTED, THE BALLOON WOULD NOT INFLATE AND THE CATHETER WAS REPLACED. THERE WAS NO INJURY TO THE PT. THE FACILITY REPORTED THAT AS THEY ATTEMPTED TO INFLATE THE BALLOON WITH FLUID, THEY VISUALIZED A BALLOON SHAPED PROTRUSION DISTAL TO THE Y-JUNCTION OF THE CATHETER. FLUID WAS ALLOWED TO PASS THROUGH THE INFLATION VALVE AND INTO THE INFLATION LUMEN. WE HAVE NO SAMPLE TO EVALUATE. A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED BUT BASED ON THE INFO PROVIDED, IT APPEARS THAT THE INFLATION VALVE FUNCTIONED PROPERLY AND FLOW WAS THEN OBSTRUCTED AT THE BIFURCATION.

    Description of Event or Problem · 1

    AFTER THE CATHETER WAS INSERTED, THE BALLOON WOULD NOT INFLATE. A NEW CATHETER WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649820 LATEX FOLEY CATHETER, 16F NWR MEDLINE INDUSTRIES, INC. 13CB2526A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other