BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 6MM INSULIN SYRINGE

    MDR report key: 6533152 · Received April 30, 2017

    Report

    Report Number
    1920898-2017-00055
    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
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: IT IS UNKNOWN IF A SAMPLE WILL BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: A LOT # WAS PROVIDED WITH THE CUSTOMER'S RETURNED SAMPLES ON 5/22/2017. THE INFORMATION FOR THIS LOT # IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5306604, MEDICAL DEVICE EXPIRATION DATE: N/A, DEVICE MANUFACTURE DATE: 11/2/2015. DEVICE EVALUATION: RESULTS: EIGHT UNUSED SAMPLES IN AN OPEN POLY BAG WERE RETURNED FOR EVALUATION. ALL RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED THE NEEDLE THROUGH THE SHIELD. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED ZERO DEFECTS OR NOTIFICATIONS NOTED FOR ANY RELATED DEFECTS DURING THE PRODUCTION OF THE REPORTED LOT # 5306604. CONCLUSION: ALTHOUGH A NEEDLE THROUGH SHIELD WAS OBSERVED WITH THE RETURNED SAMPLES, 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 SUFFERED A NEEDLE STICK INJURY BEFORE USE WITH A BD ULTRA-FINE¿ 6MM INSULIN SYRINGE BECAUSE ITS NEEDLE WAS BENT AND HAD PENETRATED ITS ORANGE CAP. THERE WAS NO REPORT OF MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314297 BD ULTRA-FINE¿ 6MM INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 5306604

    Patients

    Seq Age Sex Outcome Treatment
    1 Other