BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA® CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER AND STRAP

    MDR report key: 7516430 · Received May 15, 2018

    Report

    Report Number
    1018233-2018-01763
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Report Date
    June 8, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KNX
    UDI-DI
    00801741040757
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: ¿BARDIA CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER AND FLEXIBLE STRAP CONTENTS: 2000ML (APPROX. VOL.)/URINE SAMPLE SLEEVE ¿ 0.313¿ I.D. (7.95MM) DRAINAGE TUBE ¿ ROUND PROFILE CENTER ENTRY ¿ ANTI-REFLUX CHAMBER ¿ FLEXIBLE HOOK & LOOP CLOTH STRAP ¿ DRAW-OFF TUBE WITH CLAMP CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. DIRECTIONS FOR USE: 1. WASH HANDS. 2. REMOVE PROTECTIVE CAP FROM DRAINAGE TUBE AND CONNECT DRAINAGE TUBE ADAPTER TO CATHETER. 3. FASTEN DRAINAGE BAG TO BEDFRAME NEAR THE FOOT OF THE BED. DO NOT ALLOW BAG TO TOUCH FLOOR. IMPORTANT: HANG DRAINAGE TUBE IN A STRAIGHT FASHION FROM BEDSIDE TO DRAINAGE BAG. IF DRAINAGE BAG IS PLACED EVEN WITH PATIENT¿S HIP, COIL TUBING ALONGSIDE PATIENT. TUBING SHOULD BE DRAPED OVER PATIENT¿S LEG. 4. CHECK THAT URINE IS DRAINING INTO BAG. 5. TO EMPTY BAG: A. REMOVE OUTLET TUBE FROM HOUSING. B. RELEASE CLAMP AND EMPTY BAG. C. WHEN BAG IS EMPTY, RETURN CLAMP TO CLOSED POSITION AND REPLACE TUBE IN HOUSING. NOTE: IF SPECIMEN IS REQUIRED, SEE DIRECTIONS FOR OBTAINING URINE SAMPLE. 6. WASH HANDS. 7. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. DIRECTIONS FOR OBTAINING URINE SAMPLE: 1 . KINK TUBING A MINIMUM OF 3 INCHES BELOW SAMPLE SLEEVE UNTIL URINE IS UNDER SAMPLE SITE. 2. SWAB SURFACE OF PUNCTURE SITE WITH ANTISEPTIC WIPE. 3. INSERT NEEDLE (21G OR SMALLER) THROUGH CENTER OF PUNCTURE SITE. BE CAREFUL TO AVOID PUNCTURING OPPOSITE SIDE OF SAMPLE SLEEVE. 4. REMOVE DESIRED VOLUME OF URINE. RELEASE KINK TO PERMIT FLOW TO DRAINAGE BAG. 5. SEND SPECIMEN TO LABORATORY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT URINE STOPPED FLOWING INTO THE DRAIN BAG WHEN THE BAG WAS PARTIALLY FULL. THE PATIENT REPORTED THAT THE URINE BACKED UP WITHIN THE TUBING.

    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 URINE STOPPED FLOWING INTO THE DRAIN BAG WHEN THE BAG WAS PARTIALLY FULL. THE PATIENT REPORTED THAT THE URINE BACKED UP WITHIN THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359545 BARDIA® CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER AND STRAP DRAIN BAG KNX C.R. BARD, INC. (COVINGTON) -1018233 NGBU1144 00801741040757

    Patients

    Seq Age Sex Outcome Treatment
    1