BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11000155 · Received December 13, 2020

    Report

    Report Number
    1018233-2020-21650
    Event Type
    Malfunction
    Date Received
    December 13, 2020
    Date of Event
    November 18, 2020
    Report Date
    January 18, 2021
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE, AS NO SAMPLE RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE DUE TO "POOR PACKAGE FIT (PINCH POINTS, LOOSE)". IT WAS UNKNOWN WHETHER THE DEVICE HAD MET SPECIFICATIONS. THE PRODUCT USED FOR THE TREATMENT, BUT IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. 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. 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 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. 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 FLOOR STAND OR HANGER. URISTAND® IS NOT AVAILABLE ON PRESCRIPTION. CONTACT BARD FOR ORDERING DETAILS. TO OBTAIN PRODUCTS THAT ARE NOT AVAILABLE ON PRESCRIPTION. 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" 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 INTEGRITY OF THE BAG WAS NOT UP TO SCRATCH AND ON THE SEVERAL BAGS FROM THE LOT, THE PLASTIC KEPT ON SNAPPING NEXT TO WHERE THE LEG BAG STRAPS WERE INSERTED. IT WAS STATED THE TUBE ITSELF KEPT ON KINKING WHICH WAS OBSTRUCTING THE URINE FLOW. PER FOLLOW UP WITH IBC VIA EMAIL ON 20NOV2020, THE KINKING WAS BELIEVED TO BE CAUSED BY THE LONGER LENGTH OF TUBING AND THE USER PREFERRED A SHORTER LENGTH.

    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 INTEGRITY OF THE BAG WAS NOT UP TO SCRATCH AND ON THE SEVERAL BAGS FROM THE LOT, THE PLASTIC KEPT ON SNAPPING NEXT TO WHERE THE LEG BAG STRAPS WERE INSERTED. IT WAS STATED THE TUBE ITSELF KEPT ON KINKING WHICH WAS OBSTRUCTING THE URINE FLOW. PER FOLLOW UP WITH IBC VIA EMAIL ON 20NOV2020, KINKING WAS BELIEVED TO BE CAUSED BY THE LONGER LENGTH OF TUBING AND THE USER PREFERRED A SHORTER LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463696 LEG BAG WITH FLIP-FLO VALVE, NO STRAPS, 19 OZ., STERILE URIPLAN LEG BAG KNX C.R. BARD, INC. (COVINGTON) -1018233 NGER4590

    Patients

    Seq Age Sex Outcome Treatment
    1 Other