BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM INSTRUMENT

    MDR report key: 24854941 · Received April 13, 2026

    Report

    Report Number
    2020394-2026-00910
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 16, 2026
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741083945
    PMA / PMN Number
    K934371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: MANUFACTURING REVIEW: A DHR AND MANUFACTURING REVIEW WERE NOT REQUIRED AS THE EVENT WAS NOT CLASSIFIED AS AN UNEXPECTED EVENT, THE INVESTIGATION DID NOT IDENTIFY ANY MANUFACTURING RELATED ISSUES AND NO REPEAT FAILURES WERE FOUND DURING THE SERVICE HISTORY REVIEW. INVESTIGATION SUMMARY: THE MAGNUM DRIVER SERIAL NUMBER (B)(6) WAS RECEIVED AT THE BIP BIOMEDIZINISCHE INTSTRUMENTE UND PRODUKTE GMBH. THE MAGNUM DRIVER WAS VISUALLY INSPECTED UPON RECEIPT, AND IT WAS IN GOOD CONDITION. THE DEVICE WAS FUNCTIONALLY TESTED AND PASSED THE TEST DURING EVALUATION. NO OTHER ANOMALIES WERE IDENTIFIED. THEREFORE, THE INVESTIGATION IS DETERMINED TO BE UNCONFIRMED FOR THE REPORTED DEVICE FIRES UNINTENTIONALLY ISSUE. THE ROOT CAUSE FOR REPORTED DEVICE FIRES UNINTENTIONALLY ISSUE CANNOT BE DETERMINED AS THE PROBLEM COULD NOT BE REPRODUCED. LABELLING REVIEW: THE LABELLING/PACKAGING REVIEW WAS NOT REQUIRED AS THE REPORTED EVENT IS NOT ASSOCIATED WITH A LABELLING, PACKAGING, OR USE RELATED ISSUE. G3, H6 (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.

    Additional Manufacturer Narrative · 0

    H11: AS THE SERIAL NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WAS 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 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

    THE PATIENT WAS PREPPED FOR A BIOPSY PROCEDURE USING MAGNUM INSTRUMENT. IT WAS REPORTED THAT THE MAGNUM DRIVER FIRES UNINTENTIONALLY DURING THE RELOADING PROCESS. IT WAS FURTHER REPORTED THAT FOLLOWING THE SECOND PRIME ATTEMPT, THE MAGNUM DRIVER DISCHARGED IMMEDIATELY AFTER THE USER REMOVED THEIR FINGER FROM THE PREPARATION MECHANISM. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE PATIENT WAS PREPPED FOR A BIOPSY PROCEDURE USING MAGNUM INSTRUMENT. IT WAS REPORTED THAT THE MAGNUM DRIVER FIRES UNINTENTIONALLY DURING THE RELOADING PROCESS. IT WAS FURTHER REPORTED THAT FOLLOWING THE SECOND PRIME ATTEMPT, THE MAGNUM DRIVER DISCHARGED IMMEDIATELY AFTER THE USER REMOVED THEIR FINGER FROM THE PREPARATION MECHANISM. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922310 MAGNUM INSTRUMENT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. 00801741083945

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown