BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET

    MDR report key: 23192114 · Received October 1, 2025

    Report

    Report Number
    1018233-2025-08754
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    July 15, 2025
    Report Date
    March 19, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    FFL
    UDI-DI
    00801741111518
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED. FIVE PHOTOS WERE RECEIVED OF THE TIPLESS NITINOL STONE BASKET WITH PACKAGING.; HOWEVER, THE PHOTOS WERE NOT ABLE TO CONFIRM THE REPORTED ISSUE. RECEIVED 1 TIPLESS NITINOL STONE BASKET WITH PACKAGING. VERIFIED MATERIAL NUMBER 041900 AND BATCH NUMBER NGKP4005. SAMPLE WAS EVALUATED AND THE BASKET WAS ABLE TO OPEN AND CLOSE WITHOUT ISSUE. RISK, LABELLING, AND DHR REVIEW ARE NOT REQUIRED AS THE REPORTED EVENT WAS UNCONFIRMED. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTION: D,H. 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 INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. INITIAL REPORTER NAME: (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 THIS OCCURRED DURING SURGERY; UNABLE TO CLOSE THE STONE BASKET PROPERLY, SO USE WAS DISCONTINUED, AND A NEW BASKET WAS USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS OCCURRED DURING SURGERY; UNABLE TO CLOSE THE STONE BASKET PROPERLY, SO USE WAS DISCONTINUED, AND A NEW BASKET WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106840 BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET STONE BASKET FFL C.R. BARD INC. (COVINGTON) -1018233 NGKP4005 00801741111518

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other