BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 0.5ML 31G X 5/16 (8MM)

    MDR report key: 6533151 · Received April 30, 2017

    Report

    Report Number
    1920898-2017-00058
    Event Type
    Malfunction
    Date Received
    April 30, 2017
    Date of Event
    April 11, 2017
    Report Date
    June 14, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: ONE LOOSE SAMPLE WAS RETURNED FOR EVALUATION. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED THE CANNULA THROUGH THE SHIELD. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED ONE NOTIFICATION ((B)(4)) FOR AN UNRELATED DEFECT FOUND DURING PRODUCTION OF THIS BATCH. CONCLUSION: ALTHOUGH A NEEDLE THROUGH SHIELD WAS OBSERVED WITH THE RETURNED SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT WAS NOT DETERMINED. ADDITIONALLY, OUR QUALITY ENGINEER NOTES THAT CURRENTLY, THE PLANT UTILIZES A SYSTEM WHEREBY AN ELECTRICAL CURRENT IS PASSED OVER THE SHIELD TO DETECT SUCH DEFECTS. IMPROVEMENT PROJECTS FOR ALL NEEDLE LINES ARE UNDERWAY TO ENHANCE DETECTION CAPABILITIES OF VARIOUS DEFECTS AND EJECT THESE WHEN NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONSUMER WAS STUCK WITH A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 0.5ML 31G X 5/16 (8MM) BECAUSE THE NEEDLE WAS THROUGH ITS SAFETY CAP. THE CONSUMER APPLIED AN OVER THE COUNTER ANTISEPTIC BUT THERE WAS NO REPORT OF MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314296 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 0.5ML 31G X 5/16 (8MM) INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6004792

    Patients

    Seq Age Sex Outcome Treatment
    1 Other