BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD URINE METER WITH BAG

    MDR report key: 11720652 · Received April 23, 2021

    Report

    Report Number
    1018233-2021-02367
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    April 2, 2021
    Report Date
    October 11, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KNX
    UDI-DI
    00801741033162
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE DUE TO POOR SAMPLE CONDITION. VISUAL EVALUATION OF THE PHOTO SAMPLE NOTED ONE OPENED (WITH ORIGINAL PACKAGING) FOLEY TRAY. VISUAL INSPECTION OF THE SAMPLE NOTED THAT THE TRAY WAS OPEN WITH BOTH THE SWABS AND THE TUBING VISIBLE, BUT THE WHOLE LENGTH OF THE TUBING WAS NOT VISIBLE, SO IT CANNOT BE CONFIRMED IF THE TUBING KINKED. THE SWABS HAD THEIR TIPS POINTED TOWARD THE SYRINGES RATHER THAN THE OUTER EDGE OF THE PACKAGING, THIS DOES NOT MEET THE SPECIFICATION AS "PRODUCT CONFORMS TO PACKAGING DRAWING.¿ A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "INCORRECT ASSEMBLY OPERATION/ COMPONENTS PLACEMENT / ACCESSORIES". 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: "STERILE: CONTENTS ARE STERILE UNLESS PACKAGE IS OPENED OR DAMAGED. SINGLE USE ONLY. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LAWS AND REGULATIONS. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LAWS AND REGULATIONS. DIRECTIONS FOR USE: VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR DAMAGED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE. 1. REMOVE TRAY LID. 2. REMOVE PROTECTIVE CAP FROM CATHETER ADAPTER AND CONNECT TO A PREPARED CATHETER. 3. HANG THE BAG NEAR THE FOOT OF THE BED BY USING STRING HANGER. 4. USE SHEETING CLIP TO SECURE DRAINAGE TUBE TO SHEET. 5. IMPORTANT: HANG DRAINAGE TUBE IN A STRAIGHT FASHION FROM BEDSIDE TO DRAINAGE BAG. 6. THE URINE METER MAY BE EMPTIED IN TWO WAYS: A. TO EMPTY INTO THE BAG, GRASP THE BOTTOM OF THE METER AND LIFT UP. TO ENSURE THAT THE METER EMPTIES COMPLETELY, LIFTING AGAIN IS RECOMMENDED. B. TO EMPTY URINE METER INTO RECEPTACLE, TWIST GREEN PORTION OF DRAIN VALVE TO THE LEFT; TO CLOSE, TWIST GREEN PORTION OF THE DRAIN VALVE TO THE RIGHT. 7. TO EMPTY BAG: A. REMOVE OUTLET TUBE FROM HOUSING; GENTLY SQUEEZE CONNECTOR ARMS AND PULL TUBE FROM HOUSING. B. RELEASE CLAMP AND EMPTY BAG. C. AFTER EMPTYING, RECLAMP OUTLET TUBE AND SLIDE CONNECTOR INTO HOUSING UNTIL CONNECTOR ARMS ENGAGE. NOTE: IF SPECIMEN IS REQUIRED, SEE DIRECTIONS FOR USING URINE SAMPLE PORT. 8. PERIODIC OBSERVATIONS OF THIS SYSTEM SHOULD BE MADE TO ENSURE THAT URINE IS FLOWING FREELY. IF A STANDING COLUMN OF URINE IS OBSERVED, CHECK FOR CORRECT POSITIONING OF BAG AND THEN FOR A PHYSICAL OBSTRUCTION. IF CORRECT POSITIONING OR REMOVAL OF PHYSICAL OBSTRUCTION DOES NOT ALLOW FREE FLOW, THE BAG MAY HAVE TO BE CHANGED. 9. IF BAG IS NOT POSITIONED CORRECTLY, URINE MAY BYPASS THE METER AND GO DIRECTLY TO THE BAG. REPOSITION BAG AS NECESSARY." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING WAS FOUND TO BE SHARPLY KINKED AND ALSO IODINE SWAB STICKS WERE PLACED BACKWARDS IN THE TRAY WHILE OPENING THE NEW SURESTEP 1.1 TRAY.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING WAS FOUND TO BE SHARPLY KINKED AND ALSO IODINE SWAB STICKS WERE PLACED BACKWARDS IN THE TRAY WHILE OPENING THE NEW SURESTEP 1.1 TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611598 BARD URINE METER WITH BAG DRAIN BAG KNX C.R. BARD, INC. (COVINGTON) -1018233 153214A NGEVX103 00801741033162

    Patients

    Seq Age Sex Outcome Treatment
    1 Other