BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT FILL NEEDLE WITH FILTER

    MDR report key: 8755836 · Received July 2, 2019

    Report

    Report Number
    1911916-2019-00656
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    April 26, 2019
    Report Date
    July 31, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE LOT #: 6242815. D.4. MEDICAL DEVICE EXPIRATION DATE: 10/31/2021. H.4. DEVICE MANUFACTURE DATE: 8/29/2016. H.6. INVESTIGATION SUMMARY: ONE (1) SAMPLE AND ONE (1) PHOTO WERE RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED SAMPLE IDENTIFIED THAT THE WHITE FOREIGN MATTER REPORTED BY THE CUSTOMER WAS EPOXY DRIP OVER ON THE NEEDLES / NEEDLE HUBS. THE PHOTO PROVIDED BY THE CUSTOMER SHOWS A SERIES OF SYRINGES ALONG WITH THE COMPLAINT NEEDLE HUB ASSEMBLY SAMPLE ALL LAID OUT IN A ROW. EPOXY IS USED IN ADHERING THE CANNULA TO THE NEEDLE HUB AND IS PART OF THE NORMAL PRODUCTION PROCESS. VISUAL INSPECTION OF THE RETURNED SAMPLE IDENTIFIED THAT THE WHITE FOREIGN MATTER REPORTED BY THE CUSTOMER WAS EPOXY DRIP OVER ON THE NEEDLES / NEEDLE HUBS. AN EPOXY DRIP OVER GENERALLY OCCURS WHEN THE EPOXY APPLICATOR FAILS TO SHUT OFF FOR A MISSING CANNULA. THERE ARE SEVERAL CONTRIBUTING / POSSIBLE FACTORS. A DIRTY SENSOR THAT DOES NOT 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. BD ACKNOWLEDGES THAT THE RETURNED SAMPLES HAD EPOXY DRIP OVER ON THE NEEDLES / NEEDLE HUBS. BD HAS IMPLEMENTED THE FOLLOWING ACTIONS IN REGARDS TO EPOXY SPLATTERS AND DRIP OVERS: RE-TRAINED OPERATORS ON 8FEB2019 IN REGARDS TO INSPECTING FOR EPOXY DRIP OVERS 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. WHILE THESE ACTIONS REDUCE THE INTERACTION REQUIRED FOR THE OPERATOR IN REGARDS TO EPOXY APPLICATION, IT IS STILL DEPENDENT ON THE OPERATOR TO CONTINUOUSLY MONITOR THE ASSEMBLY PROCESS FOR EPOXY ISSUES. WE WILL CONTINUE TO PROVIDE COACHING AND FEEDBACK TO THEM AS WE BECOME AWARE OF ISSUES. AS THESE SOME OF THESE ACTIONS WERE IMPLEMENTED AFTER THE PRODUCTION OF THIS BATCH NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS WILL BE TAKEN. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    MATERIAL NO. 305211; BATCH NO. UNKNOWN (PROVIDED 6242818). IT WAS REPORTED THAT BEFORE USE OF THE BD BLUNT FILL NEEDLE WITH FILTER THERE WAS A GLUE SUBSTANCE AT THE NEEDLE ATTACHMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITE GLUE SUBSTANCE AT THE NEEDLE ATTACHMENT POSITION.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. BATCH #: BATCH NUMBER 6242818 IS NOT RECOGNIZED. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    MATERIAL NO. 305211, BATCH NO. UNKNOWN (PROVIDED 6242818). IT WAS REPORTED THAT BEFORE USE OF THE BD BLUNT FILL NEEDLE WITH FILTER THERE WAS A GLUE SUBSTANCE AT THE NEEDLE ATTACHMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITE GLUE SUBSTANCE AT THE NEEDLE ATTACHMENT POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549033 BD BLUNT FILL NEEDLE WITH FILTER MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 6242815 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other