BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT

    MDR report key: 4781793 · Received April 16, 2015

    Report

    Report Number
    2020394-2015-00481
    Event Type
    Malfunction
    Date Received
    April 16, 2015
    Report Date
    March 11, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K922939
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    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 FACILITY WAS ABLE TO PROVIDE NEW PROCEDURAL INFORMATION, WHICH WAS UPDATED IN THE APPROPRIATE SECTIONS.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER HAS BEEN PROVIDED AND THE LOT DEVICE HISTORY RECORDS HAVE BEEN REVIEWED. THE LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE DEVICE WAS NOT RETURNED FOR EVAL. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE SUSPECT DEVICE. THIS IS A KNOWN ISSUE FOR THE IDENTIFIED PRODUCT CODE/LOT NUMBER. THE ROOT CAUSE WAS DETERMINED TO BE SUPPLIER RELATED DUE TO OVER-PROCESSED RESIN. THE MONOPTY INSTRUCTIONS FOR USE (IFU) PROVIDES GENERAL INSTRUCTIONS FOR PRIMING, FIRING SAMPLING AND RETRIEVAL OF SAMPLES FROM THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY, OVER A FOUR WEEK PERIOD OF TIME, DURING MULTIPLE PROCEDURES, THE DEVICE WAS ONLY FIRING 1.0 CM INTO THE LESION TO COLLECT THE NORMAL FOUR TO FIVE TISSUE SAMPLES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256109 MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. REY12147

    Patients

    Seq Age Sex Outcome Treatment
    1