BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER

    MDR report key: 7894223 · Received September 20, 2018

    Report

    Report Number
    1018233-2018-04308
    Event Type
    Malfunction
    Date Received
    September 20, 2018
    Report Date
    December 21, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741030444
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED, UNUSED CATHETER ATTACHED TO A DRAIN BAG. THE CATHETER APPEARED RELATIVELY STRAIGHT, BUT WAS DIFFICULT TO DETERMINE WITHOUT THE ORIGINAL PACKAGING. NO OBVIOUS BENDS, DEFORMITIES OR DAMAGE TO RESTRICT FLOW WERE OBSERVED. THE CATHETER WAS FLUSHED WITH 10 ML OF METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML OF DISTILLED WATER) AND FLOWED THROUGH UNOBSTRUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WAS FOUND ADEQUATE AND STATES THE FOLLOWING: "VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. 1. OPEN CSR WRAP TO FORM STERILE FIELD. 2. PLACE UNDERPAD BENEATH PATIENT, PLASTIC SIDE DOWN. 3. PUT ON CUFFED GLOVES. 4. POSITION DRAPE ON PATIENT. 5. REMOVE TOP TRAY. 6. LUBRICATE CATHETER WHICH IS PRE-ATTACHED TO COLLECTION BAG. 7. BAG AND CATHETER MAY BE PLACED IN BASIN UNTIL NEEDED. 8. PREP PATIENT WITH POVIDONE-IODINE SWABSTICKS. 9. PROCEED WITH CATHETERIZATION IN USUAL MANNER. 10. TOP TRAY MAY BE PLACED ON BASIN TO HELP PREVENT SPILLAGE. 11. PERIODIC OBSERVATIONS OF THIS SYSTEM SHOULD BE MADE TO ASSURE THAT URINE IS FLOWING FREELY. VOLUME ON COLLECTION CONTAINER HAS BEEN CALIBRATED WITHOUT URO-PREP¿ TRAY IN PLACE. BARD AND URO-PREP ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. ©2010 C. R. BARD, INC. ALL RIGHTS RESERVED. DIRECTIONS FOR TAKING SPECIMEN: AFTER CATHETER HAS BEEN INSERTED INTO THE BLADDER AND AN INITIAL FLOW OF URINE IS SEEN IN THE COLLECTION BAG: 1. CLAMP OFF CATHETER USING WHITE CLAMP. 2. INSERT PLASTIC TUBE (INSIDE BAG) INTO THE BACK OF THE SAMPLE DEVICE. 3. OPEN SAMPLE DEVICE OVER THE SAMPLE CONTAINER. 4. UNCLAMP CATHETER. 5. ALLOW DESIRED AMOUNT OF URINE TO DRAIN INTO COLLECTION CONTAINER. 6. CLAMP OFF CATHETER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER INSIDE OF THE TRAY WAS KINKED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER INSIDE OF THE TRAY WAS KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737417 BARD® URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER URETHRAL CATHETER TRAY KOD C.R. BARD, INC. (COVINGTON) -1018233 772514 UNK 00801741030444

    Patients

    Seq Age Sex Outcome Treatment
    1