BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDIA 2000ML CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX

    MDR report key: 6079436 · Received November 4, 2016

    Report

    Report Number
    1018233-2016-01562
    Event Type
    Injury
    Date Received
    November 4, 2016
    Report Date
    October 17, 2016
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
    Product Code
    FAQ
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    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: "REMOVE PROTECTIVE CAP FROM DRAINAGE TUBE AND CONNECT DRAINAGE TUBE ADAPTER CATHETER. FASTEN DRAINAGE BAG TO BEDFRAME NEAR THE FOOT OF THE BED. DO NOT ALLOW BAG TO TOUCH FLOOR, IMPORTANT: HANG DRAINAGE TUBE IN A STRAIGHT FASHION FROM BEDSIDE TO DRAINAGE BAG. IF DRAINAGE BAG IS PLACED EVEN WITH PATIENT¿S HIP, COIL TUBING ALONGSIDE PATIENT. TUBING SHOULD BE DRAPED OVER PATIENT¿S LEG. CHECK THAT URINE IS DRAINING INTO BAG. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS." 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOLEY CATHETER DISCONNECTED FROM THE SAMPLE PORT CONNECTOR. COMPLAINANT ALLEGED THAT SHE IS USING CATHETER 123516A WITH THE DRAIN BAG. THE CATHETER DISCONNECTIONS WERE REPORTEDLY CAUSING URINE TO LEAK. THE COMPLAINANT ALLEGEDLY EXPERIENCED URINARY TRACT INFECTIONS, SEPSIS AND METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) SINCE USING THE DRAIN BAG. AS A RESULT, SHE HAS BEEN PRESCRIBED ANTIBIOTICS AND HAS REQUIRED HOSPITALIZATION FOR TREATMENT. IT WAS ALSO REPORTED THAT THE COMPLAINANT WAS USING ANTI-MICROBIAL WIPES ON THE CATHETER AND DRAIN BAG BEFORE AND AFTER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731390 BARDIA 2000ML CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX DRAIN BAG FAQ PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R