BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6751211 · Received July 28, 2017

    Report

    Report Number
    1911916-2017-00114
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    March 8, 2017
    Report Date
    July 24, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: ONE UNIT WAS RECEIVED FOR EVALUATION. VISUAL INSPECTIONS OF THE RETURNED UNIT REVEALED FOREIGN MATTER ALONG THE SHAFT OF THE NEEDLE. THE FOREIGN WAS IDENTIFIED AS ADHESIVE SPLATTER. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBERS 4181641 AND 4181640. CONCLUSION: BD WAS ABLE TO CONFIRM THE CUSTOMER'S REPORTED FAILURE MODE BASED ON THE RETURNED SAMPLE. (B)(4).

    Description of Event or Problem · 1

    THE PHARMACY TECHNICIAN REPORTED A WET, POWDERED FOREIGN MATERIAL ON THE 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532728 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE FILTER NEEDLE GAA BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS 4181641 AND 4181640

    Patients

    Seq Age Sex Outcome Treatment
    1 Other