BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8951249 · Received August 30, 2019

    Report

    Report Number
    1018233-2019-05246
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Report Date
    August 30, 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 · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED. A POTENTIAL FAILURE MODE COULD BE 'PRODUCT WITH FOREIGN OR LOOSE MATTER / HAIR.¿ WITH A POTENTIAL ROOT CAUSE OF 'DEFECTIVE / CONTAMINATED COMPONENTS FROM SUPPLIER.¿ THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. 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. COMFASURE® IS AVAILABLE ON PRESCRIPTION IN PACKS OF FIVE. 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. YOUR LOCAL AUTHORITY MAY HAVE A ¿SOILED DRESSINGS COLLECTION SERVICE¿. YOU CAN FI ND 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. FIRSTLY PEEL THE PACK OPEN AND FEED THE STRAPS SUPPLIED THROUGH THE EYELETS AT THE TOP AND BOTTOM OF THE BAG. MAKE SURE THE STRAPS SIT BEHIND THE DRAINAGE TUBE AS SHOWN AND THE ELASTICATED MATERIAL OF THE STRAP IS FACING THE LEG. THEN TO FI T THE LEG BAG TO A CATHETER OR PENILE SHEATH REMOVE THE PROTECTIVE CAP FROM THE TOP OF THE INLET TUBE ON THE LEG BAG AND PUSH THE CONNECTOR FIRMLY INTO THE CATHETER OR SHEATH OUTLET. YOU CAN WEAR THE BAG ON YOUR THIGH OR CALF DEPENDING ON WHICH SIZE OF BAG YOU PREFER. THREE VOLUME CAPACITIES AND FOUR DIFFERENT TUBE LENGTHS ARE AVAILABLE TO ORDER ACCORDING TO YOUR NEEDS. THE LEG BAGS FEATURE AN EASY TO USE LEVER DRAINAGE TAP. WHEN YOUR LEG BAG IS IN POSITION, YOU CAN OPEN THE TAP BY MOVING THE LEVER DOWNWARDS, AWAY FROM THE BODY UNTIL IT LIES FLAT. THE ARROW ON THE TOP INDICATES DIRECTION OF FLOW. TO CLOSE IT, PULL IT UPWARDS SO THAT IT RESTS AGAINST THE BAG. URISLEEVE® PROVIDES TOTAL SECURITY AND MAXIMUM COMFORT AS AN ALTERNATIVE TO LEG STRAPS.¿ THE SOFT FABRIC OF URISLEEVE® GIVES SUPPORT, APPLYING AN EVEN PRESSURE OVER THE WHOLE AREA OF THE URIPLAN® LEG BAG, HOLDING IT SECURE. URISLEEVE® IS AVAILABLE IN FOUR SIZES AND EASILY ADAPTS TO FI T ON THE CALF OR ON THE THIGH. MEASURE THE CIRCUMFERENCE OF THE WIDEST POINT OF THE THIGH (A) OR CALF (B) DEPENDING WHERE URISLEEVE® IS TO BE WORN. DETERMINE CORRECT URISLEEVE® LEG BAG HOLDER SIZE USING FITTING GUIDE BELOW. ADDED SECURITY WHEN YOU NEED IT¿ IF YOU WOULD LIKE TO BE EXTRA SURE THAT THE LEVER TAP CANNOT BE ACCIDENTLY OPENED, A URILOCK® SAFETY TAP LOCK CAN BE FITTED ONTO THE URIPLAN® BAGS. TO FI ND OUT MORE, AND TO RECEIVE FREE SAMPLES, PLEASE FILL IN YOUR DETAILS ON THE REPLY PAID SECTION AND POST IT TO US. BARD® URIPLAN® LEG BAGS, HAVE A SMOOTH, EASY TO CLEAN BACKING. IF REQUIRED A REMOVABLE COMFORT LAYER IS AVAILABLE FROM BARD WHICH IS SECURED USING THE LEG STRAPS AND CAN EASILY BE REMOVED AND WASHED. STABILIZING YOUR FOLEY CATHETER IN ORDER TO PREVENT PULLING ON YOUR FOLEY CATHETER AND AVOID TRAUMA, WE RECOMMEND THAT YOU STABILISE YOUR FOLEY CATHETER WITH AN APPROPRIATE SECUREMENT DEVICE. CHOOSE FROM AN ADHESIVE DEVICE OR POSITIONING STRAP. STATLOCK® FOLEY STABILISATION DEVICE STATLOCK® FOLEY STABILISATION DEVICE IS A NEW, STRAP FREE DEVICE WHICH IS APPLIED TO YOUR LEG OR ABDOMEN. STATLOCK® FOLEY LOCKS THE CATHETER IN PLACE. ITS UNIQUE SWIVEL CLIP ALLOWS MOVEMENT WITHOUT LOSS OF SECURITY. CONTACT BARD FOR YOUR COMPLIMENTARY PATIENT GUIDE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS HAVING FREQUENT BAG CHANGES PER DAY, USER FELT THAT THE BAG BECAME SMELLY AND DISCOLORED . THE USER ALSO SAID THAT THE TUBE OF THE LEG BAG STARTED TO LOOK "FLURRY" AS THOUGH IT IS MOLDING INSIDE. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL 27AUG2019; THE PATIENT FELT IT AS MOLD INSIDE THE TUBE, THEY GO ON TO SAY IT MANIFESTED AROUND THE 4TH DAY OF USE. IT WAS WHITE AND FROTHY, BUT THE PATIENT SAID THEY DIDN'T THINK IT WAS JUST FOAM FROM THE URINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744791 LEG BAG WITH FLIP-FLO VALVE, NO STRAPS, 19 OZ., STERILE LEG BAG KNX C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1