BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD FOLEY CATHETERIZATION TRAY URO-PREP TRAY

    MDR report key: 10279567 · Received July 15, 2020

    Report

    Report Number
    1018233-2020-04542
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Report Date
    July 15, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KNX
    UDI-DI
    00801741029622
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE COULD NOT BE CONFIRMED AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "INCORRECT OPERATION". THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "CONTENTS: URO-PREP¿ TRAY WITH: UNDERPAD, DRAPE POVIDONE-IODINE SOLUTION NPN 02076144 10CC SYRINGE (PREFILLED WITH STERILE WATER) TO INFLATE FOLEY CATHETER ONLY. LATEX-FREE, POWDER-FREE GLOVES(2) SPECIMEN CONTAINER AND LABEL LUBRICANT PACKET, FORCEPS, PREP BALLS (5) GRADUATED COLLECTION CONTAINER. DIRECTIONS FOR USE: VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. OPEN CSR WRAP TO FORM STERILE FIELD. PLACE UNDERPAD BENEATH PATIENT, PLASTIC SIDE DOWN. PUT ON CUFFED GLOVES. POSITION DRAPE ON PATIENT. REMOVE TOP TRAY. OPEN LUBRICANT. LUBRICATE CATHETER. POUR CLEANSING SOLUTION ONTO PREP BALLS. PREP PATIENT WITH SATURATED PREP BALLS. PROCEED WITH CATHETERIZATION IN USUAL MANNER. IF SPECIMEN IS REQUIRED, FILL STERILE CONTAINER FROM CATHETER. TOP TRAY MAY BE PLACED ON BASIN TO HELP PREVENT SPILLAGE. IF URINE IS PLACED IN SPECIMEN JAR: SECURE CAP. LABEL SPECIMEN JAR. SEND SPECIMEN TO LABORATORY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO IODINE PRESENT IN THE TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739720 BARD FOLEY CATHETERIZATION TRAY URO-PREP TRAY FOLEY CATHETERIZATION TRAY KNX C.R. BARD, INC. (COVINGTON) -1018233 782100 NGDX4664 00801741029622

    Patients

    Seq Age Sex Outcome Treatment
    1