BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM INSTRUMENT

    MDR report key: 23218760 · Received October 5, 2025

    Report

    Report Number
    2020394-2025-01605
    Event Type
    Malfunction
    Date Received
    October 5, 2025
    Date of Event
    April 10, 2025
    Report Date
    September 17, 2025
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K934371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: 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 DRIVER SERIAL NUMBER 51BO0118 WAS RECEIVED AT THE BIP BIOMEDIZINISCHE INTSTRUMENTE UND PRODUKTE GMBH. THE MAGNUM DRIVER WAS VISUALLY INSPECTED UPON RECEIPT AND WAS FOUND TO BE IN BAD CONDITION. THE SERIAL NUMBER IS BARELY VISIBLE. THE DEVICE WAS FUNCTIONALLY TESTED AND FAILED THE TEST DUE TO THE BAD CONDITION OF THE DEVICE FOUND DURING EVALUATION. NO OTHER ANOMALIES WERE IDENTIFIED. THEREFORE, THE INVESTIGATION IS DETERMINED TO BE INCONCLUSIVE FOR THE REPORTED BROKEN FASTENERS ON NEEDLE WHEN FIRED ISSUE AND THE INVESTIGATION IS DETERMINED TO BE CONFIRMED FOR THE IDENTIFIED SERIAL NUMBER IS BARELY VISIBLE ISSUE. THE ROOT CAUSE FOR REPORTED BROKEN FASTENERS ON NEEDLE WHEN FIRED ISSUE CANNOT BE DETERMINED AS THE DEVICE COULD NOT BE TESTED DUE TO BAD CONDITION. THE ROOT CAUSE FOR IDENTIFIED SERIAL NUMBER IS BARELY VISIBLE ISSUE CANNOT 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. 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

    A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MAGNUM, FOR AN UNKNOWN MEDICAL CONDITION. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT NEEDLE ALLEGEDLY BROKE OFF WHEN FIRING. THERE WAS NO REPORTED PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650851 MAGNUM INSTRUMENT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown