BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEG BAG WITH FLIP-FLO VALVE AND LATEX STRAPS, 32 OZ., STERILE

    MDR report key: 8549955 · Received April 25, 2019

    Report

    Report Number
    1018233-2019-02167
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Report Date
    May 28, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KNX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    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 WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿WHEN YOU GO TO BED AT NIGHT, DO NOT DISCONNECT YOUR LEG BAG FROM THE CATHETER. CONNECT A 2000ML BED BAG (URIPLAN® D813131 OR D1MT) TO THE FLEXIBLE TUBE AT THE BOTTOM OF THE LEG BAG TAP. ONCE THE TWO BAGS ARE SECURELY CONNECTED, OPEN THE TAP OF THE LEG BAG, TO ALLOW OVERNIGHT DRAINAGE OF URINE INTO THE BED BAG. IMPORTANT: REMEMBER TO CLOSE THE LEG BAG URISTAND® BED BAG HOLDER TO SUPPORT YOUR URIPLAN® BED BAG AT NIGHT IT SHOULD BE PLACED ON A FLOOR STAND OR HANGER. URISTAND® IS NOT AVAILABLE ON PRESCRIPTION. CONTACT BARD FOR ORDERING DETAILS. TO OBTAIN PRODUCTS THAT ARE NOT AVAILABLE ON PRESCRIPTION CALL SALES SUPPORT DIRECT ON 01293 606786. URIPLAN® BED BAG CODE DRAINABLE 2000ML BAG D813131 SINGLE USE DRAINABLE 2000ML BAG WITH TAP D1MT SINGLE USE DRAINABLE 2000ML BAG WITH TEAR OPTION D8420 URISTAND® BED BAG HOLDER CODE FLOOR STAND FS3** TAP BEFORE REMOVING YOUR BED BAG. DISPOSAL OF USED BAGS YOUR LOCAL AUTHORITY MAY HAVE A ¿SOILED DRESSINGS COLLECTION SERVICE¿. YOU CAN FIND OUT BY CONTACTING YOUR LOCAL COUNCIL OFFICES OR YOUR DOCTORS SURGERY. IF THIS SERVICE IS NOT AVAILABLE, YOU CAN DISPOSE OF YOUR USED BAGS THROUGH THE REFUSE COLLECTION SERVICE. EMPTY THE BAG BEFORE YOU DISPOSE OF IT WRAP THE BAG IN SEVERAL LAYERS OF NEWSPAPER OR IN A PLASTIC BAG AND SEAL THE WRAPPING SECURELY BEFORE YOU PLACE IT IN THE DUSTBIN DO NOT INCINERATE ANY USED BAGS OR OTHER EQUIPMENT INDOORS USED ITEMS MUST NOT BE FLUSHED DOWN THE TOILET, AS THIS COULD CAUSE A BLOCKAGE TO THE SEWAGE SYSTEM COMFASURE® CATHETER RETAINER STRAP EASY TO USE." CORRECTION: CONCOMITANT MEDICAL PRODUCTS, DEVICE EVALUATED BY MFR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NO URINE WOULD FLOW INTO THE LEG BAG. THIS ALLEGEDLY HAPPENED ON TWO OCCASIONS.

    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 NO URINE WOULD FLOW INTO THE LEG BAG. THIS ALLEGEDLY HAPPENED ON TWO OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343711 LEG BAG WITH FLIP-FLO VALVE AND LATEX STRAPS, 32 OZ., STERILE LEG DRAIN BAG KNX C.R. BARD, INC. (COVINGTON) -1018233 NGCU2238

    Patients

    Seq Age Sex Outcome Treatment
    1