BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM INSTRUMENT

    MDR report key: 21880341 · Received April 22, 2025

    Report

    Report Number
    2020394-2025-00597
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    March 26, 2025
    Report Date
    July 17, 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
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE SERIAL 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. 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.

    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 DRIVER WAS RECEIVED AT THE BIP BIOMEDIZINISCHE INTSTRUMENTE UND PRODUKTE GMBH. THE MAGNUM DRIVER WAS VISUALLY INSPECTED UPON RECEIPT AND WAS FOUND TO BE IN A NORMAL CONDITION. REAR BODY IS WORN OUT. THE DEVICE WAS FUNCTIONALLY TESTED AND FAILED STYLET SLED FORCE TEST IDENTIFIED DURING EVALUATION. NO OTHER ANOMALIES WERE IDENTIFIED. THEREFORE, THE INVESTIGATION IS DETERMINED TO BE UNCONFIRMED FOR THE REPORTED DEVICE TRIGGERS WHEN WOUND UP ISSUE, THE INVESTIGATION IS DETERMINED TO BE CONFIRMED FOR THE IDENTIFIED REAR BODY IS WORN OUT ISSUE AND THE INVESTIGATION IS DETERMINED TO BE CONFIRMED FOR THE IDENTIFIED STYLET SLED FORCE TEST FAILED ISSUE.THE ROOT CAUSE FOR REPORTED DEVICE TRIGGERS WHEN WOUND UP ISSUE CANNOT BE DETERMINED AS THE PROBLEM COULD NOT BE REPRODUCED. THE ROOT CAUSE FOR IDENTIFIED REAR BODY IS WORN OUT ISSUE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE ROOT CAUSE FOR IDENTIFIED STYLET SLED FORCE TEST FAILED ISSUE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. B5, E1, G2, G3, H6 (DEVICE, COMPONENT, METHOD, 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 PRIOR TO A BIOPSY PROCEDURE, THE DEVICE TRIGGERS WHEN WOUND UP. ADDITIONAL INFORMATION RECEIVED THAT A BARD NEEDLE INSTALLED WHEN THE MAGNUM DEVICE FIRED ON ITS OWN PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE MAGNUM DRIVER TRIGGERS WHEN WOUND UP. ADDITIONAL INFORMATION RECEIVED THAT A BARD NEEDLE WAS INSTALLED WHEN THE MAGNUM DRIVER FIRED ON ITS OWN PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352527 MAGNUM INSTRUMENT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. 00801741083945

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown