BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM INSTRUMENT

    MDR report key: 23507976 · Received November 10, 2025

    Report

    Report Number
    2020394-2025-01851
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 19, 2025
    Report Date
    December 18, 2025
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741083945
    PMA / PMN Number
    K934371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F ¿ THE INFORMATION PROVIDE 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

    H11: MANUFACTURING REVIEW: A DHR 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 DEVICE SERIAL NUMBER (B)(6) WAS RECEIVED AT THE BIP BIOMEDIZINISCHE INTSTRUMENTE UND PRODUKTE GMBH. THE MAGNUM DRIVER WAS VISUALLY INSPECTED UPON RECEIPT AND WAS FOUND TO BE IN NORMAL CONDITION. ADDITIONALLY, THE SEQUENCER WELDMENT HAS A LITTLE CRACK WERE NOTED. THE DEVICE WAS FUNCTIONALLY TESTED AND FAILED THE TEST DUE TO A PIECE OF PLASTIC JAMMED THE DEVICE WHICH CAUSED FAILURE TO PRIME IDENTIFIED DURING EVALUATION. NO OTHER ANOMALIES WERE IDENTIFIED. THEREFORE, THE INVESTIGATION IS DETERMINED TO BE INCONCLUSIVE FOR THE REPORTED FIRES BY ITSELF ISSUE, THE INVESTIGATION IS DETERMINED TO BE CONFIRMED FOR THE IDENTIFIED FAILURE TO PRIME ISSUE, AND THE INVESTIGATION IS DETERMINED TO BE CONFIRMED FOR THE IDENTIFIED SEQUENCER WELDMENT HAS A LITTLE CRACK ISSUE. THE ROOT CAUSE FOR REPORTED FIRES BY ITSELF ISSUE CANNOT BE DETERMINED AS THE DEVICE COULD NOT BE TESTED. THE ROOT CAUSE FOR IDENTIFIED FAILURE TO PRIME ISSUE WAS DETERMINED TO BE A PIECE OF PLASTIC JAMMED THE DEVICE IDENTIFIED DURING EVALUATION. THE ROOT CAUSE FOR IDENTIFIED SEQUENCER WELDMENT HAS A LITTLE CRACK ISSUE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. LABELING REVIEW: THE LABELLING/PACKAGING REVIEW WAS NOT REQUIRED AS THE REPORTED EVENT IS NOT ASSOCIATED WITH A LABELLING, PACKAGING, OR USE RELATED ISSUE. D4(MEDICAL DEVICE EXPIRATION DATE, UNIQUE IDENTIFIER (UDI) #), G3, H6 (DEVICE, COMPONENT, RESULT, CONCLUSION). SECTION A THROUGH F ¿ THE INFORMATION PROVIDE 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 MAGNUM DRIVER FIRES BY ITSELF AFTER COCKING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MAGNUM DRIVER FIRES BY ITSELF AFTER COCKING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407909 MAGNUM INSTRUMENT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. 00801741083945

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown