BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET

    MDR report key: 12487679 · Received September 17, 2021

    Report

    Report Number
    1018233-2021-05731
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Date of Event
    August 26, 2021
    Report Date
    March 21, 2022
    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
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED CAUSE UNKNOWN. 1 SAMPLE WAS CONFIRMED TO EXHIBIT THE REPORTED FAILURE. THE DEVICE HAS NOT MET SPECIFICATION. THE PRODUCT WAS USED FOR TREATMENT. THE PRODUCT HAS CAUSED THE REPORTED FAILURE. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), NITINOL TIPLESS SKYLITE BASKET. VISUAL INSPECTION OF THE SAMPLE NOTED THE WIRE BASKET WAS BROKEN OFF UPON RETURN. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE INADEQUATE HANDLING OF MATERIAL. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A LABELING REVIEW WAS NOT PERFORMED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. CORRECTIONS: D,H H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS EVALUATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SKYLITE BASKET WAS BROKEN WHEN TRIED TO REMOVE A KIDNEY STONE FROM A PATIENT DURING THE URETEROSCOPY. NO MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SKYLITE BASKET WAS BROKEN WHEN TRIED TO REMOVE A KIDNEY STONE FROM A PATIENT DURING THE URETEROSCOPY. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385099 BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET NITINOL BASKET FFL C.R. BARD, INC. (COVINGTON) -1018233 041900 NGFT0635 00801741111518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other