BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSN-114

    MDR report key: 3340898 · Received July 26, 2013

    Report

    Report Number
    1211566-2012-00009
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    November 15, 2012
    Report Date
    April 12, 2013
    Manufacturer
    RANFAC CORP.
    Product Code
    KNW
    PMA / PMN Number
    983187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER INVESTIGATION OF THE PRODUCT RETURNED. RANFAC CORPORATION WAS UNABLE TO REPLICATE THE INCIDENT IDENTIFIED BY THE END USER. THE STYLET RELEASES FROM THE CANNULA WITH NO DRAGGING. THE POINT APPEARED INTACT AND UNDAMAGED. THE INSIDE OF THE SNARE WAS INTACT WITH NO SIGNS OF USE. NO NON-CONFORMANCE IDENTIFIED DURING THIS INSPECTION OF THE RETURNED PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT END USER WAS UNABLE TO RETRIEVE THE SPECIMEN FROM THE NEEDLE. THE END USER INDICATED THAT THE STYLET BECAME BLOCKED IN WHICH THE CORE NEEDED TO BE CRUSHED IN ORDER TO REMOVE THE SPECIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351916 GSN-114 BONE MARROW BIOPSY NEEDLE KNW RANFAC CORP. 74026-01M 24556

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK