BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7511872 · Received May 14, 2018

    Report

    Report Number
    1018233-2018-01703
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Date of Event
    April 23, 2018
    Report Date
    June 7, 2018
    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
    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: "COMFASURE CATHETER RETAINER STRAP 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. COMFASURE® IS AVAILABLE ON PRESCRIPTION IN PACKS OF FIVE. COMFASURE® CATHETER RETAINER STRAP CODE ADULT (UP TO 65CM) AD3403 SMALL (UP TO 35CM) SM3404 ABDOMINAL AB3405 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 FL EXIBLE 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 TAP BEFORE REMOVING YOUR BED BAG. 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 TO SUPPORT YOUR URIPLAN® BED BAG AT NIGHT IT SHOULD BE PLACED ON A FL OOR 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. DISPOSAL OF USED BAGS YOUR LOCAL AUTHORITY MAY HAVE A ¿SOILED DRESSINGS COLLECTION SERVICE¿. YOU CAN FIND OUT BY CONTACTING YOUR LOAL 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."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER CONNECTED THE LEG BAG TO THE CATHETER BUT THERE WAS BLOCKAGE AND THE BAGS HAVE CHANGED FROM CLEAR TO OPAQUE. THE PATIENT'S WIFE RETURNED THE REMAINDER OF THE BOX TO THE PHARMACY.

    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 THE USER CONNECTED THE LEG BAG TO THE CATHETER BUT THERE WAS BLOCKAGE AND THE BAGS HAVE CHANGED FROM CLEAR TO OPAQUE. THE PATIENT'S WIFE RETURNED THE REMAINDER OF THE BOX TO THE PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355633 LEG BAG WITH FLIP-FLO VALVE, NO STRAPS, 19 OZ., STERILE LEG BAG KNX C.R. BARD, INC. (COVINGTON) -1018233 NGBU1429

    Patients

    Seq Age Sex Outcome Treatment
    1