BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® URINE METER WITH BAG

    MDR report key: 18382820 · Received December 22, 2023

    Report

    Report Number
    1018233-2023-09130
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Date of Event
    November 30, 2023
    Report Date
    December 28, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KNX
    UDI-DI
    00801741033117
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE IS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "INCORRECT ASSEMBLY OPERATION OF ESTANE GLUE APPLICATION IN THE URINE METER ADAPTER AND URINE METER / DRAINAGE BAG ASSEMBLY." A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATES THE FOLLOWING: "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." H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLEY CATHETER WOULD NOT DRAIN. NO DIFFICULTY WITH INSERTION BUT WHEN PRIMARY REGISTER NURSE ATTEMPTED TO DRAIN FOLEY CATHETER FROM DEPENDENT DRAIN BAG (NOT CLEAR MEASURED COLLECTION UNIT) THE SEAL ON THE WHITE SIDE AND CLEAR SIDE OF THE BAG WAS FUSED AND WOULD NOT ALLOW FOR DRAINAGE FROM DRAIN BAG. FOLEY REMAINED IN PLACE UNTIL DELIVERY UPON WHICH TIME IT WAS REMOVED WHEN PATIENT BEGAN PUSHING. NO HARM TO PATIENT OR BABY AS FOLEY WAS IN PLACE FOR A SHORT PERIOD OF TIME (LOT#NGHV3874). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 28NOV2023, CUSTOMER REPORTED THAT FOLEY CATHETER HAD A DEFECT (LOT#NGHU2373). CERVICAL DILATION BALLOON PLACED ON 11/27/23 AT 1833. CERVICAL DILATION BALLOON FOUND TO BE RUPTURED AND DEFLATED UPON ASSESSMENT . PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 30NOV2023, CUSTOMER REPORTED TWO COMPLAINTS ABOUT FOLEY CATHETERS. BOTH COMPLAINTS WERE REGARDING A FOLEY BAG BEING FUSED TOGETHER (CLEAR PLASTIC PART AND WHITE PLASTIC PART) WHICH WOULD NOT ALLOW URINE TO FILL THE ENTIRE BAG (PCN#-153204 - LOT#NGHV3874 AND PCN#153204 - LOT#NGHV3874 ).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLEY CATHETER WOULD NOT DRAIN. NO DIFFICULTY WITH INSERTION BUT WHEN PRIMARY REGISTER NURSE ATTEMPTED TO DRAIN FOLEY CATHETER FROM DEPENDENT DRAIN BAG (NOT CLEAR MEASURED COLLECTION UNIT) THE SEAL ON THE WHITE SIDE AND CLEAR SIDE OF THE BAG WAS FUSED AND WOULD NOT ALLOW FOR DRAINAGE FROM DRAIN BAG. FOLEY REMAINED IN PLACE UNTIL DELIVERY UPON WHICH TIME IT WAS REMOVED WHEN PATIENT BEGAN PUSHING. NO HARM TO PATIENT OR BABY AS FOLEY WAS IN PLACE FOR A SHORT PERIOD OF TIME (LOT#NGHV3874). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2023, CUSTOMER REPORTED THAT FOLEY CATHETER HAD A DEFECT (LOT#NGHU2373). CERVICAL DILATION BALLOON PLACED ON (B)(6) 2023 AT 1833. CERVICAL DILATION BALLOON FOUND TO BE RUPTURED AND DEFLATED UPON ASSESSMENT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2023, CUSTOMER REPORTED TWO COMPLAINTS ABOUT FOLEY CATHETERS. BOTH COMPLAINTS WERE REGARDING A FOLEY BAG BEING FUSED TOGETHER (CLEAR PLASTIC PART AND WHITE PLASTIC PART) WHICH WOULD NOT ALLOW URINE TO FILL THE ENTIRE BAG (PCN#-(B)(4) - LOT#NGHV3874 AND PCN# (B)(4) - LOT#NGHV3874).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2168872 BARD® URINE METER WITH BAG URINE METER WITH BAG KNX C.R. BARD, INC. (COVINGTON) -1018233 NGHV3874 00801741033117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other