BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM INSTRUMENT

    MDR report key: 16712713 · Received April 11, 2023

    Report

    Report Number
    2020394-2023-00241
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 28, 2023
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741083945
    PMA / PMN Number
    K934371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A DEVICE HISTORY RECORD 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 FOR EVALUATION. THE MAGNUM DRIVER WAS VISUALLY INSPECTED UPON RECEIPT AND WAS FOUND TO BE IN GOOD CONDITION. THE DEVICE WAS FUNCTIONALLY TESTED AND FAILED THE TESTS AS BROKEN LATCH PLATE CAUSING FAILED TO PRIME IDENTIFIED DURING EVALUATION. NO OTHER ANOMALIES WERE IDENTIFIED. THEREFORE, THE INVESTIGATION IS DETERMINED TO BE INCONCLUSIVE FOR THE REPORTED TOO MUCH FORCE HAD TO BE USED TO PRIME THE DRIVER. THE INVESTIGATION IS DETERMINED TO BE CONFIRMED FOR THE IDENTIFIED FAILED TO PRIME. THE ROOT CAUSE FOR THE REPORTED TOO MUCH FORCE HAD TO BE USED TO PRIME THE DRIVER CANNOT BE DETERMINED AS THE DEVICE COULD NOT BE TESTED. THE ROOT CAUSE FOR THE FOR THE IDENTIFIED FAILED TO PRIME IS DETERMINED TO BE BROKEN LATCH PLATE . LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H10: D4 (EXPIRY DATE: 12/2050), G3, H6 (DEVICE). H11: H6 (METHOD, RESULT, CONCLUSION). 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. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    AS THE LOT 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. (EXPIRY DATE: 12/2050).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY DOESN'T PRIME CORRECTLY. IT WAS FURTHER REPORTED THAT THE TOO MUCH FORCE HAD TO BE USED TO PRIME THE DRIVER. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY DOESN'T PRIME CORRECTLY. IT WAS FURTHER REPORTED THAT TOO MUCH FORCE HAD TO BE USED TO PRIME THE DRIVER. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379907 MAGNUM INSTRUMENT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. MG1522 00801741083945

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown