BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCORE DISPOSABLE CORE BIOPSY INSTRUMENT

    MDR report key: 4230503 · Received October 22, 2014

    Report

    Report Number
    2020394-2014-00460
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 24, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K922939
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WAS NO EVIDENCE FOUND THAT THE FAILURE MODE REPORTED WAS MANUFACTURING RELATED. THIS IS THE FIRST COMPLAINT REPORTED FOR THIS LOT NUMBER AND REPORTED FAILURE TO DATE. THE LOT MET ALL RELEASE CRITERIA. THREE DEVICES WERE RETURNED FOR EVALUATION, WHICH INCLUDED TWO LOT SAMPLES. A FUNCTIONAL EVALUATION WAS COMPLETED AND THE DEVICES WERE ABLE TO BE FULLY PRIMED WITH NO ISSUES. THE DEVICES WERE ABLE TO PRIME AND FIRE PROPERLY. THE INVESTIGATION IS UNCONFIRMED AS THE RETURNED DEVICE WORKED PROPERLY UNDER LABORATORY CONDITIONS. ALL RETURNED LOT SAMPLES ALSO WORKED PROPERLY UNDER LABORATORY CONDITIONS AND THE REPORTED PROBLEM COULD NOT BE RECREATED. THE ROOT CAUSE FOR THE REPORTED FAILURE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PROCEDURAL FACTORS CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    TO ENSURE COMPLIANCE TO 21 CFR 803.50 A RETROSPECTIVE REVIEW OF THIS FILE WAS CONDUCTED TO DETERMINE IF GOOD FAITH EFFORTS WERE MADE TO OBTAIN THE REQUIRED INFORMATION AND/OR AN EXPLANATION OF WHY ANY REQUIRED INFORMATION WAS NOT PROVIDED. MULTIPLE FOLLOW UP ATTEMPTS WERE MADE WITH THE FACILITY TO OBTAIN ANY INFORMATION PERTAINING TO THE PATIENT, PRODUCT, AND/OR PROCEDURAL DETAILS (E.G. DATE OF THE EVENT, RELEVANT TEST DATA, RELEVANT HISTORY, LOT #, CATALOG #, IMPLANT AND/OR EXPLANTED DATES, AND CONCOMITANT PRODUCT(S) OR THERAPY) THAT WERE NOT PREVIOUSLY OBTAINED DURING THE INITIAL INVESTIGATION. THE INTERNATIONAL REPRESENTATIVE DID NOT HAVE ANY ADDITIONAL DETAILS TO PROVIDE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KIDNEY BIOPSY, AFTER THE SECOND TISSUE SAMPLING, THE DEVICE FIRED BEFORE PUSHING THE ACTUATOR BUTTON. THERE WAS NO REPORT OF PATIENT OR USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670721 MAXCORE DISPOSABLE CORE BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. REYC0429

    Patients

    Seq Age Sex Outcome Treatment
    1