BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD URINE METER FOLEY TRAY WITH LUBRI-SIL ALL-SILICONE FOLEY CATHETER

    MDR report key: 14564138 · Received June 1, 2022

    Report

    Report Number
    14564138
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    May 22, 2022
    Report Date
    May 27, 2022
    Manufacturer
    C. R. BARD, INC.
    Product Code
    EZL
    UDI-DI
    00801741024979
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS REPORT IS FOR THE SECOND FOLEY CATHETER THAT WAS PLACED AND FAILED. A PATIENT COME BACK INTO THE EMERGENCY DEPT SAYING HIS FOLEY THAT HAD BEEN PLACED JUST FELL OUT. IT WAS A 16 FR UROMETER STYLE FOLEY AND IT HAD A PIN HOLE IN THE BALLOON ON INSPECTION. THEN WE PLACED A NEW 16 FR FOLEY AND SENT HIM HOME. HE CAME BACK AN HOUR LATER SAYING IT FELL OUT AGAIN, THIS ONE HAD A BIG VERTICAL TEAR IN THE BALLOON AND WOULD NOT INFLATE AT ALL. I SAVED THE PACKAGING BECAUSE IT WAS STILL IN THE TRASH. THEN WE PLACED AN 18 FR FOLEY AND SENT HIM HOME AGAIN. I SAVED THE PACKAGING TOO JUST IN CASE IT HAPPENS AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334728 BARD URINE METER FOLEY TRAY WITH LUBRI-SIL ALL-SILICONE FOLEY CATHETER CATHETER, RETENTION TYPE, BALLOON EZL C. R. BARD, INC. 942216 NGFW2438 00801741024979

    Patients

    Seq Age Sex Outcome Treatment
    1 29565 DA Male