BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM INSTRUMENT

    MDR report key: 20730541 · Received November 19, 2024

    Report

    Report Number
    2020394-2024-01717
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    October 23, 2024
    Report Date
    December 23, 2024
    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

    H10: AS THE SERIAL NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H11: 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.

    Additional Manufacturer Narrative · 0

    H10: 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 NORMAL CONDITION. THE SCREW HOLE FOR THE M3X12 SCREW IN THE REAR END OF THE MAIN BODY WHICH HOLDS THE REAR BODY SUB ASSEMBLY AND THE MAIN BODY IN PLACE IS DAMAGED AND THE SCREW CAN NOT BE TIGHT END AND MAIN BODY IS BEND AND COVER INDICATOR SPRING BROKEN. THE DEVICE WAS FUNCTIONALLY TESTED AND FAILED THE TESTS DUE TO LEAF SPRING FOR THE STYLET SLED IS BEND AND DID ACTIVATE THE TRIGGER IDENTIFIED DURING EVALUATION. NO OTHER ANOMALIES WERE IDENTIFIED. THEREFORE, THE INVESTIGATION IS DETERMINED TO BE CONFIRMED FOR THE REPORTED DEVICE FIRE WITHOUT PRESSING TRIGGER ISSUE AND THE INVESTIGATION IS DETERMINED TO BE CONFIRMED FOR THE IDENTIFIED DAMAGED SCREW HOLE FOR THE M3X12 SCREW IN THE REAR END OF THE MAIN BODY AND BROKEN COVER INDICATOR SPRING ISSUE AND THE INVESTIGATION IS DETERMINED TO BE CONFIRMED FOR THE IDENTIFIED MAIN BODY BEND ISSUE. THE ROOT CAUSE FOR REPORTED DEVICE FIRE WITHOUT PRESSING TRIGGER ISSUE WAS DETERMINED TO BE LEAF SPRING FOR THE STYLET SLED IS BEND AND DID ACTIVATE THE TRIGGER IDENTIFIED DURING EVALUATION. THE ROOT CAUSE FOR IDENTIFIED DAMAGED SCREW HOLE FOR THE M3X12 SCREW IN THE REAR END OF THE MAIN BODY ISSUE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE ROOT CAUSE FOR IDENTIFIED MAIN BODY BEND ISSUE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE ROOT CAUSE FOR IDENTIFIED BROKEN COVER INDICATOR SPRING 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. H11: 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 DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FIRED WITHOUT PRESSING THE TRIGGER. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FIRED WITHOUT PRESSING THE TRIGGER. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009549 MAGNUM INSTRUMENT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. 00801741083945

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown