BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD CENTER ENTRY URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER 2000ML

    MDR report key: 6053549 · Received October 25, 2016

    Report

    Report Number
    1018233-2016-01455
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Report Date
    October 5, 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
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    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: "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 DRAIN BAG WOULD NOT EMPTY THE CONTENTS. COMPLAINANT ALLEGED THAT THERE WAS SUCTION IN THE DRAIN BAG AND IN ORDER TO EMPTY THE BAG, THE CATHETER HAD TO BE DISCONNECTED. NO MEDICAL INTERVENTION WAS REQUIRED AND NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706516 BARD CENTER ENTRY URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER 2000ML DRAIN BAG KNX PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 NGAQ4339

    Patients

    Seq Age Sex Outcome Treatment
    1