BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX ALL-SILLICONE FOLEY CATHETER

    MDR report key: 3982969 · Received July 30, 2014

    Report

    Report Number
    3982969
    Event Type
    Malfunction
    Date Received
    July 30, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 30, 2014
    Manufacturer
    C.R. BARD, INC
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BEFORE USE, IT WAS NOTED THAT THIS FOLEY CATHETER HAD A HOLE AT THE JUNCTION OF CONNECTION TO TUBING. TWO CATHETERS WITH SAME LOT NUMBER WERE NOTED TO HAVE THE SAME HOLE IN THE SAME LOCATION. THEY WERE NOT USED ON A PATIENT, SO THERE WAS NO PATIENT HARM.====================== MANUFACTURER RESPONSE FOR BARDEX ALL-SILCONE FOLEY CATHETER, BARDEX (PER SITE REPORTER)======================HAVE REQUESTED PRODUCT FOR ANALYSIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446041 BARDEX ALL-SILLICONE FOLEY CATHETER CATHETER, RETENTION TYPE, BALLOON EZL C.R. BARD, INC * NGXL2449
    446042 BARDEX ALL-SILLICONE FOLEY CATHETER CATHETER, RETENTION TYPE, BALLOON EZL C.R. BARD, INC * NGXL2449

    Patients

    Seq Age Sex Outcome Treatment
    1 *