BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEG BAG WITH FLIP-FLO VALVE, NO STRAPS, 19 OZ., STERILE

    MDR report key: 9786803 · Received March 4, 2020

    Report

    Report Number
    1018233-2020-01517
    Event Type
    Malfunction
    Date Received
    March 4, 2020
    Report Date
    March 23, 2020
    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 REPORTED EVENT WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL FAILURE MODE COULD BE ¿BAG WILL NOT EXPAND/VINYL STUCK TOGETHER¿ WITH A POTENTIAL ROOT CAUSE OF ¿STATIC OR POSITIVE AIR PRESSURE¿. 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: "EASY TO USE SOFT ELASTICATED COMFASURE® HAS AN ANTI-SLIP BACKING. IT¿S UNIQUE, EASY-TO-OPERATE RETAINER CLIP SECURES WITH A ¿CLICK¿ - SUPPORTING CATHETER OR DRAINAGE BAG TUBING. EASY TO CHOOSE COMFASURE® IS AVAILABLE IN THREE SIZES. TO DETERMINE THE CORRECT SIZE NEEDED, MEASURE THE CIRCUMFERENCE OF THE WIDEST POINT OF THE THIGH (A) OR ABDOMEN. OVERNIGHT LINK SYSTEM: 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." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE URINE WOULD NOT FLOW AT THE CORRECT RATE INTO THE LEG DRAIN BAG. IT OCCURRED AT THE JUNCTION OF THE CATHETER AND THE TUBING. THE USER SAID IT WAS LIKE THE BAG WAS SEALED TOGETHER.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE URINE WOULD NOT FLOW AT THE CORRECT RATE INTO THE LEG DRAIN BAG. IT OCCURRED AT THE JUNCTION OF THE CATHETER AND THE TUBING. THE USER SAID IT WAS LIKE THE BAG WAS SEALED TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253338 LEG BAG WITH FLIP-FLO VALVE, NO STRAPS, 19 OZ., STERILE LEG DRAIN BAG KNX C.R. BARD, INC. (COVINGTON) -1018233 NGCV2089

    Patients

    Seq Age Sex Outcome Treatment
    1 Female