BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE 1/2 ML, 29G

    MDR report key: 6145388 · Received December 5, 2016

    Report

    Report Number
    1920898-2016-00044
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 10, 2016
    Report Date
    December 19, 2016
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K941657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - THE CUSTOMER RETURNED (1) 1/2 CC, 12.7 MM, 29G SYRINGE IN AN OPEN POLY BAG FROM LOT # 6032951. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED THE NEEDLE THROUGH THE SHIELD. SINCE THE NEEDLE WAS THROUGH THE SHIELD, EXPOSING THE CANNULA, A NEEDLE STICK COULD OCCUR. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE REPORTED LOT # 6032951. ALL CHALLENGES AND INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THIS PRODUCT WAS PACKAGED 22MAR2016 TO 24MAR2016. CONCLUSION - BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. A PROBABLE ROOT CAUSE IS MISALIGNMENT OF THE ROLLOVER BAR TO THE NEEDLE ASSEMBLY RACK AT THE SHIELDING OPERATION. OCCASIONALLY, A RACK JAM WILL OCCUR IN THE TRACKS AT THE SHIELDER AND CAUSE THE MACHINE TO GO OUT OF TIME, MISALIGNING THE RACKS. WHEN THIS HAPPENS THE RACKS DO NOT LINE UP WITH THE HOLES IN THE ROLLOVER BAR. WHEN THE ROLLOVER BAR ROLLS OVER TO PUT THE SHIELD ON THE HUB THE CANNULA MAY GO THROUGH THE WALL OF THE SHIELD CAUSING A NEEDLE THROUGH SHIELD DEFECT. CORRECTIONS ARE FOLLOWS: THE NEEDLE LINE MANUFACTURING PROCESS INCLUDES A POINT INSPECT MACHINE (PIM) WHICH INSPECTS THE NEEDLE FOR EXCESSIVE ANGULARITY, POINT DAMAGE, EXCESSIVE/INSUFFICIENT ADHESIVE, DOUBLE CANNULA, MISSING CANNULA AND CLOGGED CANNULA. THE PIM IS CHALLENGED FOR RECOGNITION OF THE MENTIONED DEFECTS AT THE BEGINNING OF EACH SHIFT AND APPROXIMATELY 4 HOURS THEREAFTER PER APPROPRIATE QC DOCUMENTATION. THE ASSEMBLY MACHINES ARE ALSO EQUIPPED WITH A SYSTEM THAT SENDS AN ELECTRICAL CHARGE THROUGH THE NEEDLE ASSEMBLY AND IF A CANNULA IS THRU THE SHIELD IT EJECTS THE NEEDLE ASSEMBLY INTO A WASTE BIN. THE NEEDLE THRU SHIELD DETECT SYSTEM IS CHALLENGED AT THE START OF EACH SHIFT OF OPERATION PER APPROPRIATE QC DOCUMENTATION. OCCASIONALLY WHEN THE SYSTEM ARCS AND DETECTS A NEEDLE THRU THE SHIELD, THE VALVE TO EJECT THE PART TURNS ON BUT THE PART GETS CAUGHT IN THE RAIL AND CONTINUES THROUGH THE MACHINE AND IS ASSEMBLED TO A BARREL. MARS (MAGNETIC ANGULARITY REDUCTION SYSTEM) INSTALLED AND VALIDATED ON ALL NEEDLE LINES THROUGHOUT THE (B)(4) FACILITY. PROCESS CREATED TO TRAIN ASSOCIATES TO CLEAR THE LINE OF ALL RACKS INVOLVED IN A JAM. PROCESS CREATED TO TRAIN ASSOCIATES TO REMOVE LUMEN BLOW TEST SAMPLES FROM THE LINE BEFORE THE GET TO THE SHIELDER OPERATION. NEEDLE BENT CAMERA WAS INSTALLED TO DETECT BENT CANNULA BD WILL CONTINUE TO MONITOR FOR TRENDS AND SPECIAL CAUSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TRAINING, THE NEEDLE PIERCED THROUGH THE SHIELD AND THE DOCTOR STUCK HIM/HERSELF WITH THE UNUSED NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795396 BD ULTRA-FINE¿ INSULIN SYRINGE 1/2 ML, 29G INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6032951

    Patients

    Seq Age Sex Outcome Treatment
    1 Other