BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DILATION PRODUCTS

    MDR report key: 25074384 · Received May 4, 2026

    Report

    Report Number
    1018233-2026-02924
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 8, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    FBW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    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 STATED 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 THE PATIENT EXPERIENCED TISSUE TRAUMA ASSOCIATED WITH USE OF THE X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER ADDITIONALLY, THE PHYSICIAN STATED THAT THE PATIENT EXPERIENCED PERFORATION ASSOCIATED WITH USE OF THE X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629493 UNKNOWN DILATION PRODUCTS DILATION PRODUCT FBW C.R. BARD INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other