BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD LUBRICATH FOLEY CATHETER TRAY

    MDR report key: 6075262 · Received November 1, 2016

    Report

    Report Number
    MW5065770
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    September 27, 2016
    Report Date
    November 1, 2016
    Manufacturer
    BARD MEDICAL AND UROLOGICAL
    Product Code
    EZL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE WAS CONTINUING THE CATHETER. BALLOON DEFLATED UNTIL NO MORE FLUID WAS ABLE TO BE PULLED FROM BALLOON PORT. NURSE PULLED CATHETER OUT AND BALLOON WAS NOT DEFLATED ENTIRELY. NURSE ATTEMPTED TO DEFLATE BALLOON AFTER IT WAS OUT OF PT BY ASPIRATING AT THE BALLOON PORT, BUT BALLOON WOULD NOT DEFLATE. PT SUFFERED SEVERE PAIN AND BLEEDING AT URETHRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722501 BARD LUBRICATH FOLEY CATHETER TRAY BARD LUBRICATH FOLEY CATHETER TRAY EZL BARD MEDICAL AND UROLOGICAL 899916

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other