BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD DISPOZ-A-BAG LEG BAG WITH FLIP-FLO DRAINAGE VALVE

    MDR report key: 6002478 · Received October 6, 2016

    Report

    Report Number
    1018233-2016-01350
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Report Date
    October 17, 2016
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
    Product Code
    KNX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    RECEIVED 1 USED LEG BAG ONLY. VISUAL INSPECTION NOTED NO OBVIOUS DEFECTS ON THE SAMPLE RECEIVED. THE SAMPLE WAS INSPECTED AND DID NOT FIND ANY FOLDS IN THE FLUTTER VALVE THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE SAMPLE WAS RECEIVED WITHOUT DRAINAGE TUBING. PER THE FUNCTIONAL EVALUATION, THE SAMPLE RECEIVED WAS TESTED WITH AN EXTENSION TUBE (NOT PART OF THE SAMPLE RECEIVED) CONNECTED TO A NEW 16 FR. CATHETER (NOT PART OF THE SAMPLE RECEIVED). THE SAMPLE WAS TESTED PASSING WATER THROUGH OF NEW 16 FR. CATHETER, AND NOTED LIQUID FLOWING TOWARD THE INTERIOR OF THE BAG UNTIL IT WAS FILLED TO ITS MAXIMUM CAPACITY. DURING THE TEST, IT WAS NOT NOTED THAT THE FLOW STOPPED. THE FLOW WAS CONTINUOUS. THE LIQUID OF THE LEG BAG WAS THEN DRAINED TO THE EXTERIOR OF THE BAG AND DID NOT NOTE ANY DIFFICULTY OR PROBLEM TO DRAIN. ADDITIONALLY, THE VINYL'S WERE CUT TO VERIFY THE EMBOSSED OF THE BAG TO BE CORRECT ON THE SAMPLE RECEIVED AND NO PROBLEM NOTED ON THE EMBOSSED. AFTER THAT, THE BAG WAS CUT CHECKED THE EMBOSSED ON THE FLUTTER VALVE ON THE SAMPLE RECEIVED. REVIEWED THE INLET TUBE OF THE BAG WHERE THE FLUTTER VALVE WAS SEALED FOR ANY TYPE OF OBSTRUCTION AND NO PROBLEM WAS FOUND. REVIEWED THAT THE FLUTTER VALVE WAS NOT BENT OR DID NOT HAVE ANY TYPE OF OBSTRUCTION AND NO PROBLEM WAS FOUND. REVIEWED THE EMBOSSED OF THE FLUTTER VALVE, WHICH WAS ON THE EXTERNAL PART; THEREFORE, THE ASSEMBLY WAS FOUND CORRECT. REVIEWED THE EMBOSSED OF THE CLEAR VINYL OF THE LEG BAG, WHICH WAS ON THE INTERNAL PART; THEREFORE, THE ASSEMBLY WAS FOUND CORRECT. REVIEWED THE PERIPHERAL SEAL, ROTARY SEAL OF THE BAG AND NO PROBLEM WAS FOUND. NO PROBLEM COULD BE NOTICED ON THE FLUTTER VALVE ON THE SAMPLE RECEIVED. THE REPORTED ISSUE WAS UNCONFIRMED AS THE PROBLEM COULD NOT BE REPRODUCED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "POSITION BAG ON LEG WITH FLUTTER VALVE AT TOP. ATTACH CATHETER OR EXTENSION TUBING TO TOP INLET. WHEN WEARING BAG BELOW KNEE, ATTACH BARD® EXTENSION TUBING (CATALOG NO. 150615 OR 4A4194). WHEN USING EXTENSION TUBING, MAKE SURE TO CONNECT TUBE AT LEAST TO THE 3RD TAPER OF THE CONNECTOR. TO EMPTY DISPOZ-A-BAG®, PUSH GREEN LEVER ON FLIP-FLO VALVE OUT AND DOWN. STRAPS AND 18" LATEX-FREE EXTENSION TUBING." 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.

    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 URINE WOULD NOT FLOW FREELY THROUGH THE DRAINAGE TUBING INTO THE LEG BAG. IT WAS NOTED THAT THE URINE APPEARED TO BE BACKED UP WITHIN THE TUBING. AS A RESULT, THE DEVICE WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE URINE WOULD NOT FLOW FREELY THROUGH THE DRAINAGE TUBING INTO THE LEG BAG. IT WAS NOTED THAT THE URINE APPEARED TO BE BACKED UP WITHIN THE TUBING. AS A RESULT, THE DEVICE WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE URINE WOULD NOT FLOW FREELY THROUGH THE DRAINAGE TUBING INTO THE LEG BAG. IT WAS NOTED THAT THE URINE APPEARED TO BE BACKED UP WITHIN THE TUBING. AS A RESULT, THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660578 BARD DISPOZ-A-BAG LEG BAG WITH FLIP-FLO DRAINAGE VALVE LEG BAG KNX PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1