BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD URINE DRAINAGE COLLECTION BAG

    MDR report key: 183966 · Received August 21, 1998

    Report

    Report Number
    MW1014460
    Event Type
    Malfunction
    Date Received
    August 21, 1998
    Report Date
    August 21, 1998
    Manufacturer
    C.R. BARD, INC.
    Product Code
    EYZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RPTR WRITES, "SINCE OUR DISCUSSION OF APRIL 21ST WE HAVE CONTINUED TO HAVE PROBLEMS WITH THE BARD URINE DRAINAGE COLLECTION BAGS. AS YOU KNOW, THESE BAGS WILL SELF ADHERE AND PREVENT URINE DRAINAGE IF THE VENT LOCATED ON THE FRONT OF THE BAG GETS WET. PER YOUR SUGGESTION, WE DID EDUCATION WITH STAFF ABOUT THE NEED TO KEEP THE VENT DRY. WE HAVE FOUND THAT IN SPITE OF ALL OUR EFFORTS, IN ROUTINE CARE OF PATIENTS IN CLINICAL SETTINGS (REPOSITIONING, MOVING FROM STRETCHER TO BED ETC) THE COLLECTED URINE DOES SATURATE THE VENT. EACH TIME THE VENT BECOMES SATURATED, THE URINE COLLECTION BAG MUST BE REPLACED OR THERE IS THE RISK OF THE SIDES OF THE BAG STICKING TOGETHER AND PREVENTING URINE DRAINAGE. WE BELIEVE THE DESIGN OF THE BAG IS FLAWED; THE VENT PLACEMENT ALLOWS FOR EASY SATURATION AND MALFUNCTION. HAVE YOU CONSIDERED A CHANGE IN THE DESIGN OF THE PRODUCT? I AM INTERESTED IN HEARING FROM YOU WITH ADDITIONAL SUGGESTIONS TO PREVENT FUTURE PROBLEMS WITH THE BARD BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD URINE DRAINAGE COLLECTION BAG URINE DRAINAGE COLLECTION BAG EYZ C.R. BARD, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other