BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6751048 · Received July 28, 2017

    Report

    Report Number
    1911916-2017-00186
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    June 9, 2017
    Report Date
    July 26, 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

    THREE LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE FOLLOWING INFORMATION IS FOR EACH LOT NUMBER: MEDICAL DEVICE LOT #: 4181639; MEDICAL DEVICE EXPIRATION DATE: 8/31/2019; DEVICE MANUFACTURE DATE: 6/30/2014. MEDICAL DEVICE LOT #: 4181640; MEDICAL DEVICE EXPIRATION DATE: 9/30/2019; DEVICE MANUFACTURE DATE: 6/30/2014. MEDICAL DEVICE LOT #: 4181641; MEDICAL DEVICE EXPIRATION DATE: 9/30/2019; DEVICE MANUFACTURE DATE: 6/30/2014. RESULTS: SAMPLES WERE NOT RETURNED FOR EVALUATION, HOWEVER, THE CUSTOMER PROVIDED FOUR PHOTOS FOR INVESTIGATION. A PHOTO INSPECTION REVEALED AN EPOXY DRIPOVER DOWN THE SIDE OF THE HUB. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBERS. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. HOWEVER, OUR QUALITY ENGINEER NOTES THAT A POSSIBLE ROOT CAUSE MAY AN EPOXY APPLICATOR FAILURE FOR A MISSING CANNULA. THERE ARE SEVERAL CONTRIBUTING / POSSIBLE FACTORS. A DIRTY SENSOR THAT DOESN'T SHUT THE EPOXY OFF FOR A MISSING CANNULA; THE EPOXY PRESSURE IS TOO HIGH. THE EPOXY APPLICATOR NEEDS ATTENTION ¿ IT ISN¿T SHUTTING OFF WHEN IT SHOULD. THE EPOXY VISCOSITY IS ALSO RELATED TO TEMPERATURE FLUCTUATIONS. IF THE TEMPERATURE GOES UP, THE EPOXY GETS THINNER AND FLOWS FASTER. A FORMAL CAPA HAS NOT BEEN INITIATED. HOWEVER, THE FOLLOWING THINGS HAVE BEEN DONE TO IMPROVE EPOXY DRIPOVER: RE-TRAINED OPERATORS IN REGARDS TO INSPECTING FOR EPOXY DRIPOVERS AND IDENTIFY EPOXY ISSUES; MODIFIED THE LINE TO PREVENT MIS-ASSEMBLED CANNULA FROM ACCUMULATING AND CAUSING EPOXY ON THE CATERPILLAR BELTS AND OTHER NEEDLES; REVISED THE VISUAL INSTRUCTION FOR EPOXY APPLICATION TO ASSIST THE OPERATORS IN ADJUSTING THE ADHESIVE CAMERA. THE ADHESIVE CAMERA IS USED TO ASSIST THE ASSEMBLY ASSOCIATE WITH EPOXY ADJUSTMENTS IN REGARDS TO EPOXY LOCATION. IT IS NOT USED TO DISPOSITION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY OF 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLES BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530622 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE FILTER NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other