BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANGNUM REUSABLE CORE BIOPSY INSTRUMENT

    MDR report key: 1974739 · Received December 28, 2010

    Report

    Report Number
    2020394-2010-00374
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K934371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND THE LOT MET ALL RELEASE CRITERIA. ALL DOCUMENTATION ASSOCIATED WITH THE MANUFACTURING AND ASSEMBLY OF THIS INSTRUMENT AND ITS COMPONENTS HAVE BEEN REVIEWED. THE REVIEW INDICATED THAT ALL PROCESSES AND SPECIFICATIONS WERE WITHIN ALLOWABLE PARAMETERS. THERE WERE NO ISSUES WITH RAW MATERIAL TESTING, MANUFACTURING PROCESS, AND QUALITY CONTROL INSPECTION, THERE WERE NO DEVIATIONS FOUND. THE DEVICE MET ALL RELEASE CRITERIA. THE DEVICE WAS RETURNED FOR EVALUATION. COMPONENT DAMAGE WAS CONFIRMED. IT WAS DETERMINED THAT THE REUSABLE DEVICE HAD BEEN CLEANED WITH A CHEMICAL THAT CAUSED COMPONENT DAMAGE TO THE SLEDS (DISTORTION) AND COCKING SLIDE. THIS DISTORTION PREVENTED THE DEVICE FROM ENERGIZING PROPERLY. THE ROOT CAUSE OF THE COMPONENT DAMAGE WAS IMPROPER DEVICE MAINTENANCE BY THE CUSTOMER. COMPONENTS, THE COCKING SLIDE AND THE MAIN SHAFT ASSEMBLY WERE REPLACED. THE DEVICE WAS CLEANED, LUBRICATED AND WILL BE RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KIDNEY BIOPSY AS THE PRIMED DEVICE WAS BEING INSERTED THROUGH THE SKIN, THE DEVICE FIRED OFF WITHOUT THE FIRE BUTTON BEING DEPRESSED. THE DEVICE SAMPLED FATTY TISSUE, AND DID NOT CAUSE INJURY TO THE PATIENT. THE DEVICE WAS RE-ENERGIZED AND USED TO COMPLETE THE KIDNEY BIOPSY PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANGNUM REUSABLE CORE BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1