BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® URINE METER WITH BAG

    MDR report key: 22577920 · Received July 23, 2025

    Report

    Report Number
    1018233-2025-06067
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    July 16, 2025
    Report Date
    September 19, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    KNX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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: SECTIONS 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

    UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR IS NOT REPORTABLE AS THE ALLEGATION WAS AGAINST A DRAIN BAG. SUBMITTING THE INVESTIGATION DETAILS AS ADDITIONAL INFORMATION. THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS, AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE LABELING IS FOUND TO BE ADEQUATE. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS 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 BY THE CUSTOMER THAT THE LAST 3 ITEMS OF THE BAGS WERE LEAKING WHEN THE PATIENT TRIED TO USE THEM. WAREHOUSE (B)(4) (B)(6) 2025 (B)(6). WE HAVE ALREADY CREDITED/REPLACED PRODUCT FOR OUR CUSTOMER. ITEM# 153204.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE LAST 3 ITEMS OF THE BAGS WERE LEAKING WHEN THE PATIENT TRIED TO USE THEM. WE HAVE ALREADY CREDITED/REPLACED PRODUCT FOR OUR CUSTOMER. ITEM# 153204.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2725955 BARD® URINE METER WITH BAG URINE METER DRAIN BAG KNX C.R. BARD INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other