BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOZ-A-BAG, LEG BAG WITH FLIP-FLO DRAINAGE VALVE

    MDR report key: 24815867 · Received April 8, 2026

    Report

    Report Number
    1018233-2026-02235
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    March 30, 2026
    Report Date
    May 5, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    FAQ
    UDI-DI
    00801741050862
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD IDENTIFIED A CASE OF PATIENT HARM POTENTIALLY ASSOCIATED WITH A LEG BAG. A LEG BAG 150732 HAD BEEN APPLIED UPSIDE DOWN BY A NURSE, THIS CAUSED AN ISSUE URINE DRAINAGE. AS A CONSEQUENCE, THE PATIENT SUBSEQUENTLY REQUIRED A RETURN TO SURGERY. ADDITIONAL DETAILS WERE REQUESTED FROM THE ACCOUNT, AND A FOLLOW UP REPORT WAS TO BE SUBMITTED UPON RECEIPT OF FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373344 DISPOZ-A-BAG, LEG BAG WITH FLIP-FLO DRAINAGE VALVE LEG BAG FAQ C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741050862

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention