BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM INSTRUMENT

    MDR report key: 22402469 · Received July 4, 2025

    Report

    Report Number
    2020394-2025-00972
    Event Type
    Malfunction
    Date Received
    July 4, 2025
    Date of Event
    March 7, 2025
    Report Date
    June 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
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 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. THE SLED POSITION INDICATOR FADED AND DEVICE MARKINGS UNREADABLE ON THE REAR BODY AND THE REAR COVER AND BOTH NEED TO BE UPDATED. THE DEVICE WAS FUNCTIONALLY TESTED AS DEVICE CAN BE ABLE TO PRIME & FIRE. HOWEVER, DEVICE FAILED THE COVER FORCE TEST, CANNULA SLED FORCE TEST AND STYLET SLED FORCE TEST ARE OUT OF SPECIFICATION IDENTIFIED DURING EVALUATION. NO OTHER ANOMALIES WERE IDENTIFIED. THEREFORE, THE INVESTIGATION IS DETERMINED TO BE UNCONFIRMED FOR THE REPORTED DEVICE IS JAMMED AND WONT FIRE, THE INVESTIGATION IS DETERMINED TO BE CONFIRMED FOR THE IDENTIFIED SLED POSITION INDICATOR FADED, THE INVESTIGATION IS DETERMINED TO BE CONFIRMED FOR THE IDENTIFIED COVER FORCE TEST, CANNULA SLED FORCE TEST AND STYLET SLED FORCE TEST ARE OUT OF SPECIFICATION AND THE INVESTIGATION IS DETERMINED TO BE CONFIRMED FOR THE IDENTIFIED DEVICE MARKINGS UNREADABLE ON THE REAR BODY ISSUE. THE ROOT CAUSE FOR REPORTED DEVICE IS JAMMED AND WONT FIRE ISSUE CANNOT BE DETERMINED AS THE PROBLEM COULD NOT BE REPRODUCED. THE ROOT CAUSE FOR IDENTIFIED SLED POSITION INDICATOR FADED ISSUE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE ROOT CAUSE FOR IDENTIFIED COVER FORCE TEST, CANNULA SLED FORCE TEST AND STYLET SLED FORCE TEST ARE OUT OF SPECIFICATION ISSUE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE ROOT CAUSE FOR IDENTIFIED DEVICE MARKINGS UNREADABLE ON THE REAR BODY ISSUE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. LABELING REVIEW: THE LABELING/PACKAGING REVIEW WAS NOT REQUIRED AS THE REPORTED EVENT IS NOT ASSOCIATED WITH A LABELING, 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 AND IT WAS REPORTED THAT THE DEVICE WAS JAMMED AND WONT FIRE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051429 MAGNUM INSTRUMENT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. 00801741083945

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown