BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DILATION PRODUCT

    MDR report key: 25060127 · Received May 1, 2026

    Report

    Report Number
    1018233-2026-02756
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 7, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    FBW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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: 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 CRITICAL CARE NURSES IN AN ONLINE SURVEY THAT REPORTING ON BEHALF OF A RESPONDENT THAT INDICATED THE FOLLOWING COMPLAINT IN AN ONLINE CHART AUDIT: IN THE ONLINE SURVEY A PHYSICIAN STATED THAT NO, HE OR SHE WAS NOT ABLE TO SUCCESSFULLY DILATE THE NEPHROSTOMY TRACT BECAUSE "I DID NOT USE IT FOR A PCNL". ADDITIONALLY, THE PHYSICIAN STATED THAT NO, THE PATIENT WAS NOT STONE FREE AT PROCEDURE COMPLETION. IN RELATION TO X FORCE NEPHROSTOMY BALLOON DILATION CATHETER WITHOUT EAGLE INFLATION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320259 UNKNOWN DILATION PRODUCT DILATION PRODUCT FBW C.R. BARD INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other