BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ U-40 INSULIN SYRINGE

    MDR report key: 7570062 · Received June 5, 2018

    Report

    Report Number
    1920898-2018-00368
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    May 4, 2018
    Report Date
    June 21, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K941657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) 1CC, 12.7MM, 29G BD U40 INSULIN SYRINGES IN A SEALED POLY BAG FROM LOT # 7233919. CUSTOMER STATES THAT THE NEEDLE COVER WAS MISSING AND THE NEEDLE INJURED A CUSTOMER. THE RETURNED POLY BAG WAS EXAMINED AND EXHIBITED ONE SYRINGE WITH A MISSING SHIELD. THE MISSING SHIELD LEADS TO AN EXPOSED CANNULA WHICH COULD CAUSE A NEEDLE STICK. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7233919. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. INVESTIGATION CONCLUSION: POSSIBLE ROOT CAUSE IS LIKELY DURING THE AUTO PACKAGING OPERATION THAT THE SHIELD COULD CATCH ON THE OUTSIDE OF THE CARTON AND WHEN THE PRODUCT TAMP STATION PRESSES THE AIR OUT OF THE BAGS THE SHIELD COULD BE REMOVED EXPOSING THE CANNULA. THIS WOULD LIKELY PROCEED THROUGH THE SYSTEM UNDETECTED UNLESS IT WAS DETECTED DURING HOURLY VISUAL INSPECTIONS FOR MISSING COMPONENTS. MANUFACTURING HAS NOT TAKEN ADDITIONAL STEPS FOR DETECTION OF THIS DEFECT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    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 BY A CONSUMER THAT ONE OF THE NEEDLE CAPS FOR A BD MICRO-FINE¿ U-40 1ML INSULIN SYRINGE WAS FOUND MISSING PRIOR TO USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411027 BD MICRO-FINE¿ U-40 INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7233919

    Patients

    Seq Age Sex Outcome Treatment
    1 Other