BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE

    MDR report key: 7838205 · Received August 31, 2018

    Report

    Report Number
    1911916-2018-00481
    Event Type
    Malfunction
    Date Received
    August 31, 2018
    Date of Event
    August 13, 2018
    Report Date
    September 18, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MEDICAL DEVICE LOT #: 5175577. DEVICE MANUFACTURE DATE: 06/25/2015. INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED FOR EVALUATION. IT HAS AN EPOXY DRIPOVER, AND A BROKEN HUB THEREFORE FAILURE MODE IS VERIFIED. THIS PRODUCT IS A BULK NEEDLE, WHICH THE CUSTOMER ATTACHED TO THE ADAPTER THEY MANUFACTURE. WE HAVE HAD BROKEN HUBS DURING ASSEMBLY PREVIOUSLY. THEY ARE CAUSED BY STRIKING THE ASSEMBLY EQUIPMENT RESULTING IN A STRAIGHT BREAK AT THE BASE OF THE HUB RIBS. THE RETURNED SAMPLED HAS A SPIRAL BREAK THROUGH THE CURED EPOXY. THE BREAK THROUGH THE CURED EPOXY INDICATES THAT THE BREAK OCCURRED ON THE COMPLETED NEEDLE. THIS LEADS US TO BELIEVE THAT THE BREAK OCCURRED WHEN THE PART WAS TORQUED ON TO THE ADAPTER BY THE CUSTOMER. EPOXY DRIPOVERS OCCUR WHEN THE EPOXY APPLICATOR FAILS TO SHUT OFF 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. HERE ARE THE THINGS WE'VE DONE TO IMPROVE EPOXY SPLATTERS AND DRIPOVERS: 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. 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. 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. ONE-HUNDRED FOUR VISUAL INSPECTIONS WERE PERFORMED ON 5,350 PARTS WITH ZERO DEFECTS NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD¿ NEEDLE HAD EPOXY ON THE HUB, HAD CRACKS, AND LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 9080101 WAS REPORTED BUT IS NOT VALID FOR THIS PRODUCT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD¿ NEEDLE HAD EPOXY ON THE HUB, HAD CRACKS, AND LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680967 BD¿ NEEDLE NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 5175577

    Patients

    Seq Age Sex Outcome Treatment
    1 Other