BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUBRI-SIL IC COMPLETE CARE FOLEY TRAY #16FR

    MDR report key: 3120510 · Received May 20, 2013

    Report

    Report Number
    3120510
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BARD
    Product Code
    EYC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) FEMALE ADMITTED FOR RETROPUBIC MID-URETHRAL SLING AND CYSTOSCOPY. FOLLOWING COMPLETION OF THE CYSTOSCOPY, A BARD FOLEY CATHETER WAS INSERTED. THE CATHETER WAS VISUALLY INTACT AT THE TIME OF INSERTION. THE REST OF THE PROCEDURE WAS COMPLETED. AT THE COMPLETION OF THE PROCEDURE, THE BLADDER WAS FILLED WITH 150 CC NORMAL SALINE FOR VOIDING TRIAL. THE BALLOON ON THE FOLEY WAS ASPIRATED TO DEFLATE, BUT NO RETURN WAS RECEIVED. WHEN THE FOLEY CATHETER WAS REMOVED, IT WAS NOTICED THAT THE FULL CIRCUMFERENCE OF THE BALLOON WAS NOT CONNECTED TO THE CATHETER. AN ADD'L CYSTOSCOPY WAS PERFORMED AND THE BALLOON FRAGMENT WAS REMOVED WITH A GRASPER FORCEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222738 LUBRI-SIL IC COMPLETE CARE FOLEY TRAY #16FR FOLEY CATHETER EYC BARD

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention