BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM DRIVER

    MDR report key: 12868102 · Received November 24, 2021

    Report

    Report Number
    2020394-2021-01981
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    October 28, 2021
    Report Date
    December 12, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741083945
    PMA / PMN Number
    K934371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A DEVICE HISTORY RECORD REVIEW 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 A GOOD CONDITION, CUSTOMER HAS ENGRAVED DIANOSTIC IMAGING 2021 ON COVER. ALSO, IN LATCH PLATE ASSEMBLY STYLET CATCH SPRING IS BENT, THE LOWER SUPPORT PLATE OF THE LATCH PLATE ASSEMBLY IS ALSO LOOSE AND DEVICE WAS FOUND TO BE DRY. THE DEVICE WAS FUNCTIONALLY TESTED AND FAILED THE TESTS DUE TO FAILURE OF THE LATCH PLATE ASSEMBLY OF THE DEVICE. NO OTHER ANOMALIES WERE IDENTIFIED. THE ROOT CAUSE DETERMINED TO BE IN LATCH PLATE ASSEMBLY, STYLET CATCH SPRING IS BENT AND THE LOWER SUPPORT PLATE OF THE LATCH PLATE ASSEMBLY IS ALSO LOOSE THESE FACTORS CAUSES TO AUTO FIRE AFTER SECOND COCKING. THE INVESTIGATION IDENTIFIED THE FOLLOWING THAT WOULD LIKELY TO HAVE CONTRIBUTED TO THE REPORTED EVENT IS DEVICE WAS DRY THIS WOULD BE REASON FOR SELF ACTIVATION ISSUE. 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. BD RECOMMENDS THE MAGNUM INSTRUMENT BE CLEANED AND LUBRICATED AFTER EVERY USE TO ENHANCE THE PERFORMANCE AND LONGEVITY OF THE INSTRUMENT. SILICONE FREE, QUALITY MEDICAL GRADE LUBRICANT COMPATIBLE WITH STEAM STERILIZATION SHOULD BE USED TO LUBRICATE MAGNUM INSTRUMENT. REFER TO THE MANUFACTURER'S INSTRUCTION TO DETERMINE COMPATIBILITY AND FOR THE USE OF THE SELECTED LUBRICATING AGENT. ENSURE ALL MOVING PARTS OF THE MAGNUM INSTRUMENT ARE LUBRICATED. END - USERS MAY STERILE THE INSTRUMENT AFTER EACH CLEANING AND LUBRICATION H10: D4 (EXPIRY DATE: 07/2025), G3, H6 (DEVICE) H11: H6 (RESULT, CONCLUSION). 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. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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. (EXPIRY DATE: 07/2025).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY AUTO FIRED AFTER SECOND COCKING. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY AUTO FIRED AFTER SECOND COCKING. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769404 MAGNUM DRIVER BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. MG1522 00801741083945

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown