BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP FOLEY TRAY SYSTEM BARD LUBRI-SIL FOLEY CATHETER TRAY

    MDR report key: 7989530 · Received October 22, 2018

    Report

    Report Number
    7989530
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Date of Event
    October 16, 2018
    Report Date
    October 19, 2018
    Manufacturer
    C. R. BARD, INC
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FOLEY CATHETER WAS PLACED PRIOR TO OPERATING ROOM FOR PLANNED CESAREAN SECTION (C/S). AFTER C/S COMPLETE, THE DOCTORS PERFORMED FUNDAL MASSAGE AND FOLEY CATHETER FELL OUT. THE FOLEY BALLOON WAS ONLY INFLATED ON ONE SIDE. THE FLUID WAS REMOVED, AND IT PROVED THERE WAS 10CC IN BALLOON. IT WAS RE-INFLATED MULTIPLE TIMES (OUTSIDE OF PATIENT) AND ONLY INFLATED ON ONE SIDE. REQUIRED A REPLACEMENT OF NEW FOLEY CATHETER IN PATIENT. REF # ON PACKAGE A942214.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833431 SURESTEP FOLEY TRAY SYSTEM BARD LUBRI-SIL FOLEY CATHETER TRAY CATHETER, RETENTION TYPE, BALLOON EZL C. R. BARD, INC A942214 1320723222110720104532A

    Patients

    Seq Age Sex Outcome Treatment
    1 14235 DA