BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DILATION PRODUCTS

    MDR report key: 25062423 · Received May 3, 2026

    Report

    Report Number
    1018233-2026-02900
    Event Type
    Malfunction
    Date Received
    May 3, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 11, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    FBW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    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. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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 CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY ON BEHALF OF A RESPONDENT WHO INDICATED THE FOLLOWING COMPLAINT IN AN ONLINE CHART AUDIT: IN THE ONLINE SURVEY, A PHYSICIAN STATED THAT NO, HE/SHE WAS NOT ABLE TO SUCCESSFULLY SUSTAIN PRESSURE AND DEFLATE THE BALLOON BECAUSE 'MANUAL PROBLEM, NOT DIRECTLY ATTRIBUTABLE TO THE PRODUCT.' THIS IS IN RELATION TO THE X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER WITH EAGLE INFLATION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307932 UNKNOWN DILATION PRODUCTS DILATION PRODUCT FBW C.R. BARD INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other