BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6805642 · Received August 18, 2017

    Report

    Report Number
    1911916-2017-00192
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Date of Event
    July 24, 2017
    Report Date
    August 3, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 4181639, MEDICAL DEVICE EXPIRATION DATE: 2019-08-31, DEVICE MANUFACTURE DATE: 2014-11-11; MEDICAL DEVICE LOT #: 4181641, MEDICAL DEVICE EXPIRATION DATE: 2019-09-30, DEVICE MANUFACTURE DATE: 2014-11-11; MEDICAL DEVICE LOT #: 4181640, MEDICAL DEVICE EXPIRATION DATE: 2019-09-30, DEVICE MANUFACTURE DATE: 2014-11-11. RESULTS: A SAMPLE OR PHOTO WAS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED FOR THE INCIDENT LOTS AND NO ISSUES WERE IDENTIFIED. CONCLUSION: BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE NO SAMPLES OR PHOTOS WERE RECEIVED TO CONFIRM THE STATED DEFECT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER AND OTHER PARTICULATES WERE FOUND ON A 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585948 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE FILTER NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other