BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BULK, NON-STERILE NEEDLE

    MDR report key: 8793300 · Received July 16, 2019

    Report

    Report Number
    1911916-2019-00700
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Date of Event
    June 12, 2019
    Report Date
    July 31, 2019
    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

    INVESTIGATION: ONE HUNDRED ELEVEN (111) SAMPLES AND TWO (2) PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. ONE (1) PHOTO SHOWS TEN (10) NEEDLE HUB ASSEMBLIES WITH THE NEEDLE SHIELDS REMOVED. THERE APPEARS TO BE A WHITE SUBSTANCE ON THE NEEDLE HUB ASSEMBLIES. THE OTHER PHOTO SHOWS SEVERAL ASSEMBLED NEEDLE HUBS WITH THE NEEDLE SHIELDS STILL ON THE NEEDLE HUB ASSEMBLIES. THERE APPEARS TO BE A WHITE SUBSTANCE ON THE NEEDLE HUB ASSEMBLIES UNDER THE NEEDLE SHIELDS. ONE HUNDRED ELEVEN (111) SAMPLES WERE RECEIVED FROM THE CUSTOMER FOR INVESTIGATION ON (B)(6) 2019. THE SAMPLES WERE DIVIDED INTO MULTIPLE BAGGIES BEING LABELED AS SPILLED EPOXY. ALL ONE HUNDRED ELEVEN (111) SAMPLES WERE VISUALLY EXAMINED USING UNAIDED VISION. ONE HUNDRED NINE (109) SAMPLES WHICH WERE LABELED AS SPILLED EPOXY HAD EPOXY DRIP OVER ON THE NEEDLE HUB ASSEMBLY. ONE (1) SAMPLE WAS LABELED AS HAVING AN INVERTED NEEDLE BUT VISUAL INSPECTION REVEALED THAT THERE WAS A SECOND (2ND) NEEDLE ATTACHED TO THE NEEDLE HUB WITH EPOXY AND ONE (1) SAMPLE WAS LABELED AS CRACKED AND WAS FOUND TO HAVE A CRACKED NEEDLE HUB. 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 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 MIS-ASSEMBLY AT THE CANNULATION OPERATION CAUSES A DOUBLE CANNULA. A NEEDLE MISSES THE HUB, AND FALLS ON TO THE ADJACENT NEEDLE ON THE RACK. IF THE OPERATOR DOES NOT SEE IT, THE EPOXY CURES, AND THE SECOND CANNULA STICKS TO THE ASSEMBLED NEEDLE. THE DVT CAMERA THAT INSPECTS FOR EPOXY MAY CATCH THIS DEFECT IF THE DEFECT IS ON THE SIDE FACING THE CAMERA. IT IS ESSENTIALLY THE RESPONSIBILITY OF THE ASSEMBLY ASSOCIATE TO MONITOR FOR THESE DEFECTS, CORRECT THE ISSUE, AND REMOVE THE AFFECTED NEEDLES. ROOT CAUSE FOR THE DAMAGED HUB IS UNDETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEW REVEALED THAT IT WAS REPORTED THAT ISSUES WITH THE CANNULATOR WERE REPORTED DURING THE PRODUCTION OF THIS BATCH WHICH CAN LEAD TO EPOXY DRIP OVERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD¿ BULK, NON-STERILE NEEDLE UPON INSPECTION OF BATCH NUMBER 890978 OF THE 1250 SAMPLES THAT WERE INSPECTED 40 NEEDLES WERE FOUND TO HAVE A FOREIGN MATTER OF EPOXY ON THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT (B)(6) 2019, AT INCOMING INSPECTION FOR NEEDLES FROM (CAT. # 9080101, BATCH 8290978), DURING A TEST FOR A SAMPLE OF 1,250 NEEDLES, 40 NEEDLES FOUND WITH EXCESS EPOXY ON THE HUB. THE BATCH HAS BEEN MOVED TO MRB STATUS & QUARANTINE. THE NEEDLES WERE FOUND IN BAGS #: 112, 043, 035, 031.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD¿ BULK, NON-STERILE NEEDLE UPON INSPECTION OF BATCH NUMBER 890978 OF THE 1250 SAMPLES THAT WERE INSPECTED 40 NEEDLES WERE FOUND TO HAVE A FOREIGN MATTER OF EPOXY ON THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT (B)(6) 2019, AT INCOMING INSPECTION FOR NEEDLES FROM (CAT. # 9080101, BATCH 8290978), DURING A TEST FOR A SAMPLE OF (B)(4) NEEDLES, 40 NEEDLES FOUND WITH EXCESS EPOXY ON THE HUB. THE BATCH HAS BEEN MOVED TO MRB STATUS & QUARANTINED. THE NEEDLES WERE FOUND IN BAGS #: 112, 043, 035, 031.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589165 BD¿ BULK, NON-STERILE NEEDLE NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8290978

    Patients

    Seq Age Sex Outcome Treatment
    1 Other