BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM INSTRUMENT

    MDR report key: 15824236 · Received November 18, 2022

    Report

    Report Number
    2020394-2022-00906
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    October 24, 2022
    Report Date
    December 5, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741083945
    PMA / PMN Number
    K934371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE SERIAL NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 03/2027).

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A DEVICE HISTORY RECORD REVIEW AND MANUFACTURING REVIEW WAS NOT REQUIRED AS THE EVENT WAS DETERMINED TO BE EXPECTED AND THE INVESTIGATION DID NOT IDENTIFY ANY MANUFACTURING AND/OR SERVICE-RELATED ISSUES. INVESTIGATION SUMMARY: THE MAGNUM DRIVER WAS RECEIVED FOR EVALUATION. THE MAGNUM DRIVER WAS VISUALLY INSPECTED UPON RECEIPT AND FOUND TO BE IN GOOD OVERALL CONDITION. THE DEVICE FOR FUNCTIONALLY TESTED AND PASSED THE TESTS AS GUN PRIMED AND FIRED AS NORMAL. NO OTHER ANOMALIES WERE IDENTIFIED. THEREFORE, THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED GUN IS DISENGAGED WITHOUT WARNING. THE ROOT CAUSE CANNOT BE DETERMINED AS THE PROBLEM COULD NOT BE REPRODUCED FOR THE REPORTED DEVICE SELF-ACTIVATION ISSUE. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H10: D4 (EXPIRY DATE: 03/2027), G3. H11: B3, H6 (RESULT, CONCLUSION). H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, WHEN THE GUN IS LOADED, ONE OUT OF EVERY THREE TIMES IT DISENGAGED WITHOUT WARNING. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, WHEN THE GUN IS LOADED, ONE OUT OF EVERY THREE TIMES IT DISENGAGED WITHOUT WARNING. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231943 MAGNUM INSTRUMENT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. MG1522 00801741083945

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown