BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD CENTER ENTRY CLOSED SYSTEM URINARY DRAINAGE BAG AND EZ-LOK

    MDR report key: 6180345 · Received December 16, 2016

    Report

    Report Number
    1018233-2016-01823
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Report Date
    December 7, 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
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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 STATES THE FOLLOWING: "- VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE. - PERIODIC OBSERVATIONS OF THIS SYSTEM SHOULD BE MADE TO ENSURE THAT URINE IS FLOWING FREELY. IF A STANDING COLUMN OF URINE IS OBSERVED, CHECK FOR CORRECT POSITIONING OF BAG AND THEN FOR A PHYSICAL OBSTRUCTION. IF CORRECT POSITIONING OR REMOVAL OF PHYSICAL OBSTRUCTION DOES NOT ALLOW FREE FLOW, THE BAG MAY HAVE TO BE CHANGED." (B)(4). 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 BAG TUBING WAS TOO LONG. AS A RESULT, THE PATIENT WAS ALLEGEDLY TRIPPING ON THE TUBING UPON MOBILIZATION. IT WAS ALSO REPORTED THAT THE DRAINAGE SYSTEM FROM THE TUBING INTO THE BAG WAS NOT WORKING PROPERLY AND WAS NOT ALLOWING FOR DRAINAGE OF THE URINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833452 BARD CENTER ENTRY CLOSED SYSTEM URINARY DRAINAGE BAG AND EZ-LOK LEG BAG KNX PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1