BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE

    MDR report key: 6745679 · Received July 26, 2017

    Report

    Report Number
    1911916-2017-00040
    Event Type
    Malfunction
    Date Received
    July 26, 2017
    Date of Event
    November 15, 2016
    Report Date
    July 19, 2017
    Manufacturer
    BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS
    Product Code
    GAA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTOS OF THE AFFECTED UNIT WERE RECEIVED FOR EVALUATION. A REVIEW OF THE PROVIDED PHOTOS CONFIRMED THE PRESENCE OF A WHITE PIECE OF MATERIAL IN THE SYRINGE BARREL. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBER 4121747. WITHOUT THE ACTUAL SAMPLE TO EXAMINE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THE INITIAL REPORTER (B)(6) PERFORMED AN INVESTIGATION ON THE ACTUAL SAMPLE AND IDENTIFIED THE FOREIGN MATTER AS A PAPER MATERIAL. THIS MATERIAL IS NOT UTILIZED DURING BD'S MANUFACTURING PROCESS. WHEN OR HOW THE FOREIGN WAS INTRODUCED IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING THE 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE. AFTER DRAWING UP AN EYLEA DOSE, A WHITE SEDIMENT WAS OBSERVED INSIDE THE SYRINGE WHERE THE RUBBER IS. THE SEDIMENT EXTENDED APPROXIMATELY 2/3 THE WIDTH OF THE SYRINGE. AS A RESULT, THE PREPARED DOSE/SYRINGE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523367 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE FILTER NEEDLE GAA BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS 4121747

    Patients

    Seq Age Sex Outcome Treatment
    1 Other