BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BULK, NON-STERILE NEEDLE

    MDR report key: 7249665 · Received February 7, 2018

    Report

    Report Number
    1911916-2018-00014
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    January 15, 2018
    Report Date
    February 21, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SUPPLIER RESPONSE: DHR REVIEW: BATCH 4123881 ¿ (B)(4) VISUAL INSPECTIONS WERE PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS OR ISSUES NOTED. BATCH 3329365 ¿ (B)(4) VISUAL INSPECTIONS WERE PERFORMED ON (B)(4) PARTS WITH ONE DEFECT NOTED FOR CLOGGED NEEDLES. BOTH BATCHES WERE ASSEMBLED ON NIP LINE 1. POSSIBLE ROOT CAUSE: AN EPOXY DRIPOVER GENERALLY OCCURS 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. CORRECTIVE / PREVENTATIVE ACTIONS: HERE ARE THE THINGS WE¿VE DONE TO IMPROVE EPOXY 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. WITH REGARDS TO THE BROKEN HUB: A CRACKED HUB SUCH AS THE RETURNED SAMPLE WILL NOT ADHERE TO THE ASSEMBLY RACK THROUGHOUT THE ENTIRE ASSEMBLY PROCESS, IT WOULD FALL OFF THE RACK PRIOR TO SHIELDING AS THE RACK IS INVERTED AT THE LUBE STATION, AND RETURNED TO AN UPRIGHT POSITION PRIOR TO SHIELDING.

    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 #: 4123881; MEDICAL DEVICE EXPIRATION DATE: N/A; DEVICE MANUFACTURE DATE: 2014-05-03. MEDICAL DEVICE LOT #: 3329365; MEDICAL DEVICE EXPIRATION DATE: N/A; DEVICE MANUFACTURE DATE: 2013-11-25. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED DAMAGED (CRACKS AND EPOXY ON THE NEEDLE HUB) BD¿ BULK, NON-STERILE NEEDLE(S). THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90885 BD¿ BULK, NON-STERILE NEEDLE NON-STERILE NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other