BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER

    MDR report key: 7718560 · Received July 25, 2018

    Report

    Report Number
    1018233-2018-03030
    Event Type
    Injury
    Date Received
    July 25, 2018
    Report Date
    September 19, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KNX
    UDI-DI
    00801741029516
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "BARD® URINARY DRAINAGE BAG 2 - ENGLISH C. R. BARD , INC. COVINGTON, GEORGIA 30014 USA WWW.BARDMEDICAL.COM 1-888-367-2273 AUTHORIZED REPRESENTATIVE: BARD LIMITED FOREST HOUSE BRIGHTON ROAD CRAWLEY, WEST SUSSEX RH11 9BP UK DIRECTIONS FOR USE: VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE. 1. REMOVE PROTECTIVE CAP FROM DRAINAGE TUBE CATHETER ADAPTER AND CONNECT DRAINAGE TUBE TO CATHETER. 2. POSITION HANGER ON BEDSIDE RAIL, USING STRING OR HOOK. 3. USE SHEETING CLIP TO SECURE DRAINAGE TUBE TO SHEET. IMPORTANT: HANG DRAINAGE TUBE IN A STRAIGHT FASHION FROM BEDSIDE TO DRAINAGE BAG. ENSURE THAT THE DRAINAGE BAG IS PLACED NEAR THE FOOT OF THE BED. 4. IF USING A URINE METER, IT 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 POSITION OF THE DRAIN VALVE TO THE RIGHT. 5. 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. 6. 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. 7. IF BAG IS NOT POSITIONED CORRECTLY, URINE MAY BYPASS THE METER AND GO DIRECTLY TO THE BAG. REPOSITION BAG AS NECESSARY. DIRECTIONS FOR USING BARD EZ-LOK® SAMPLING PORT: BARD EZ-LOK® SAMPLING PORT ACCEPTS A LUER-LOCK OR SLIP TIP SYRINGE. 1. KINK DRAINAGE TUBING A MINIMUM OF 3 INCHES BELOW THE SAMPLING PORT UNTIL URINE IS VISIBLE UNDER THE ACCESS SITE. 2. SWAB SURFACE OF SITE WITH ANTISEPTIC WIPE. 3. USING ASEPTIC TECHNIQUE, POSITION THE SYRINGE IN THE CENTER OF THE SAMPLING PORT. THE SYRINGE SHOULD BE HELD PERPENDICULAR TO THE SURFACE OF THE SAMPLING PORT (AT APPROXIMATELY 80-100 DEGREE ANGLE). PRESS THE SYRINGE FIRMLY AND TWIST GENTLY TO LOCK THE SYRINGE ONTO THE SAMPLING PORT. NOTE: IMPROPER PENETRATION TECHNIQUE COULD CAUSE FORMATION OF A DROP OF URINE ON THE SURFACE OF THE SAMPLING PORT. PERIODIC OBSERVATION OF THE SAMPLING PORT IS RECOMMENDED. 4. ASPIRATE DESIRED VOLUME OF URINE. 5. UNKINK TUBING AND SEND SPECIMEN TO LABORATORY. FOR UROLOGICAL USE ONLY. MANUFACTURED IN MEXICO DO NOT REUSE. DO NOT RESTERILIZE. STERILE UNLESS PACKAGE IS OPENED OR DAMAGED. PATENT NOS. 4,936,837 AND 6,651,956 BARD AND EZ-LOK ARE REGISTERED TRADEMARKS OF C. R. BARD, INC. OR AN AFFILIATE. CONTROL-FIT IS A TRADEMARK OF C. R. BARD, INC. OR AN AFFILIATE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A URINARY TRACT INFECTION FOLLOWING USE OF THE DRAIN BAG. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.

    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. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A URINARY TRACT INFECTION FOLLOWING USE OF THE DRAIN BAG. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561798 BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER DRAIN BAG KNX C.R. BARD, INC. (COVINGTON) -1018233 UNK 00801741029516

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention