BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE

    MDR report key: 22396287 · Received July 3, 2025

    Report

    Report Number
    1018233-2025-05491
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    July 2, 2025
    Report Date
    October 2, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    FAD
    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 INITIAL REPORTER'S PHONE NUMBER: (B)(6). THE REPORTED EVENT WAS INCONCLUSIVE. THE CONDITIONS OF THE SAMPLE DID NOT ALLOW FURTHER EVALUATION. VISUAL EVALUATION OF THE RETURNED ONE-PHOTO SAMPLE NOTED ONE OPENED (WITH ORIGINAL PACKAGING), USED URETERAL INLAY STENT. VISUAL INSPECTION OF THE ONE-PHOTO SAMPLE NOTED UNABLE TO CONFIRM THE CONDITION OF THE AFFECTED CATHETER DUE TO ONLY PHOTO PROVIDED FOR INVESTIGATION. FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED IF ONLY BASED ON THE ATTACHED PHOTO. THEREFORE, THE REPORTED EVENT IS INCONCLUSIVE DUE TO POOR SAMPLE CONDITION. THE LABELING IS FOUND TO BE ADEQUATE TO FULFILL S03FA211 REVISION 27. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTIONS: D, 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. INITIAL REPORTER PHONE: (B)(6). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DOUBLE-J CATHETER STENTS WAS BROKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DOUBLE-J CATHETER STENTS WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128829 BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE URETERAL STENT FAD C.R. BARD INC. (COVINGTON) -1018233 NGJW1371

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other