BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URIPLAN LEG BAG DRUG TARIFF

    MDR report key: 5652039 · Received May 12, 2016

    Report

    Report Number
    1018233-2016-00630
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Report Date
    June 3, 2016
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
    Product Code
    KNX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RECEIVED 1 UNOPENED URIPLAN LEG BAG IN THE ORIGINAL UNIT PACKAGING. VISUAL INSPECTION NOTED NO OBVIOUS DEFECTS. A FUNCTIONAL EVALUATION WAS PERFORMED BY INTRODUCING WATER THROUGH THE INLET TUBE AND NO DRAINAGE ISSUES WERE OBSERVED. THE LEG BAG WAS CUT TO VERIFY THAT THE VINYL WAS PROPERLY SEALED. THE VINYL WAS FOUND TO BE WITHIN SPECIFICATIONS. THE COMPLAINT WAS UNCONFIRMED AS THE PROBLEM COULD NOT BE REPRODUCED. 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: "INSTRUCTIONS FOR CHOOSE THE CORRECT SIZE OF STRAP: -IS AVAILABLE IN THREE SIZES. TO DETERMINE THE CORRECT SIZE NEEDED, MEASURE THE CIRCUMFERENCE OF THE WIDEST POINT OF THE THIGH (A) OR ABDOMEN. INSTRUCTIONS OF USE WHEN THE LEG BAG IS CONNECTED TO BED BAG: - 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. INSTRUCTIONS TO PLACE THE STRAPS IN THE BAG: - 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 ELASTICIZED MATERIAL OF THE STRAP IS FACING THE LEG." (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S DAUGHTER REPORTED ISSUES WITH THE BATCH OF LEG BAGS. AT LEAST SIX LEG BAGS HAD PROBLEMS. WHEN THE NIGHT BAG WAS REMOVED, IT CAUSED SUCTION AROUND THE TUBING OF THE LEG BAG; MEANING THAT NO URINE COULD ENTER THE LEG BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305692 URIPLAN LEG BAG DRUG TARIFF LEG BAG KNX PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 NGZK2430

    Patients

    Seq Age Sex Outcome Treatment
    1