BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER TRAY, 16F

    MDR report key: 4258822 · Received November 10, 2014

    Report

    Report Number
    1417592-2014-00102
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 5, 2014
    Report Date
    November 5, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING THE TRANSVAGINAL ULTRASOUND, WHEN ATTEMPTING TO REMOVE THE FOLEY CATHETER, THE BALLOON WOULD NOT DEFLATE. THE UROLOGIST PERFORMED A CYSTOSCOPY, INSERTED A GUIDEWIRE INTO THE INFLATION LUMEN OF THE CATHETER AND RUPTURED THE BALLOON. THE CATHETER WAS THEN REMOVED. THE FACILITY REPORTED THAT NO PATIENT INJURY RESULTED AND NO FURTHER INTERVENTION WAS INDICATED. THE CATHETER WAS RETURNED FOR EVALUATION AND WAS MISSING THE INJECTION ARM OF THE CATHETER. IT HAD A GUIDEWIRE INSERTED INTO THE INFLATION LUMEN. THE BALLOON WAS NOT COMPLETELY DEFLATED AND CONTAINED APPROXIMATELY 2-3 ML OF FLUID. UPON REMOVAL OF THE GUIDEWIRE, THE BALLOON DID NOT PASSIVELY DEFLATE. UPON INSPECTION, THE INFLATED EYE WAS FOUND TO BE OCCLUDED AND THE EYE SLIT WAS COLLAPSED. THE ISSUE WAS CONFIRMED WITH THE RETURNED SAMPLE.

    Description of Event or Problem · 1

    THE BALLOON WOULD NOT DEFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721616 FOLEY CATHETER TRAY, 16F NWR MEDLINE INDUSTRIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention