BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEG BAG

    MDR report key: 22702074 · Received August 4, 2025

    Report

    Report Number
    1018233-2025-06454
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 31, 2025
    Report Date
    October 3, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    FAQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. INSTRUCTIONS FOR USE WERE REVIEWED FOR THIS INVESTIGATION. THE LABELING IS FOUND TO BE ADEQUATE. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. 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 PATIENT COULD NOT VERIFY THE EXACT PCN, BUT THEY KNOW IT WAS A BARD DISPOZ-A-BAG, POSSIBLY A 150832. HE SAID BOTH HE AND THE HOSPITAL HAD DIFFICULTY GETTING THE BAG TO DRAIN PROPERLY. LMS REP ADVISED TO TRY RUNNING WATER THROUGH THE BAD IN CASE HE IS EXPERIENCING BACK FLOW. PATIENT ALSO SAID THERE WAS ABOUT 8IN OF URINE SITTING IN THE TUBING ABOVE THE FLUTTER VALVE. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    PT SAID HE COULD NOT VERIFY THE EXACT PCN, BUT HE KNOWS IT'S A BARD DISPOZ-A-BAG, POSSIBLY A 150832. HE SAID BOTH HE AND THE HOSPITAL HAD DIFFICULTY GETTING THE BAG TO DRAIN PROPERLY. LMS REP ADVISED TO TRY RUNNING WATER THROUGH THE BAD IN CASE HE IS EXPERIENCING BACK FLOW. PATIENT ALSO SAID THERE WAS ABOUT 8IN OF URINE SITTING IN THE TUBING ABOVE THE FLUTTER VALVE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199934 LEG BAG LEG BAG FAQ C.R. BARD INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other