BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE

    MDR report key: 21504516 · Received March 3, 2025

    Report

    Report Number
    1018233-2025-01406
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 13, 2025
    Report Date
    July 18, 2025
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FAD
    UDI-DI
    10801741014557
    PMA / PMN Number
    K983498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. 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 IS INCONCLUSIVE. VISUAL EVALUATION NOTED RECEIVED STENT ALONG WITH 2 PHOTOS OF THE TOP VIEW OF STENT HOWEVER PRODUCT RETURNED IS NOT A BARD PRODUCT THEREFORE THE SAMPLE CANNOT BE EVALUATED FOR THE REPORTED EVENT. THE LABELLING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE BAW IS ATTACHED IN THE INVESTIGATION OVERVIEW TAB. DHR REVIEW IS NOT REQUIRED AS NO LOT NUMBER WAS REPORTED FOR THE INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION NO ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME. CORRECTIONS: D, E, H. 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 THAT THERE ARE CREASES ON THE DOUBLE J OF THE URETERAL STENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE ARE CREASES ON THE DOUBLE J OF THE URETERAL STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634616 BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE URETERAL STENT FAD C.R. BARD, INC. (COVINGTON) -1018233 UNK 10801741014557

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other