BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO FINE PLUS ¿ PEN INJECTOR NEEDLE

    MDR report key: 7531788 · Received May 22, 2018

    Report

    Report Number
    9616656-2018-00113
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    May 10, 2018
    Report Date
    June 14, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO OPEN AND FOURTEEN SEALED 32G X 6MM PEN NEEDLE SAMPLES ALONG WITH FOUR PHOTOS WERE RETURNED FROM LOT. NO. 7172737, CAT. NO. 320738. VISUAL EXAMINATION OF RETURNED SAMPLES AND PHOTOS WAS CARRIED OUT AND A BROKEN NON PATIENT END OF NEEDLE WAS OBSERVED ON ONE OPENED SAMPLE, NO ISSUES WERE OBSERVED WITH THE SECOND OPEN SAMPLE OR THE FOURTEEN SEALED SAMPLES. INVESTIGATION CONCLUSION: VISUAL EXAMINATION OF RETURNED SAMPLES AND PHOTOS WAS CARRIED OUT AND A BROKEN NON PATIENT END OF NEEDLE WAS OBSERVED ON ONE OPENED SAMPLE, NO ISSUES WERE OBSERVED WITH THE SECOND OPEN SAMPLE OR THE FOURTEEN SEALED SAMPLES. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    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 WITH THE USE OF THE BD MICRO FINE PLUS¿ PEN INJECTOR NEEDLE THERE WAS AN ISSUE WITH A BROKEN NEEDLE. IT WAS STATED ¿WHEN INJECTED, THE PATIENT COULDN'T PRESS THE BUTTON AND THE NEEDLE WAS BROKEN WHEN REMOVED FROM THE SKIN". THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378146 BD MICRO FINE PLUS ¿ PEN INJECTOR NEEDLE PEN INJECTOR NEEDLE FMI BECTON DICKINSON AND CO. 7172737

    Patients

    Seq Age Sex Outcome Treatment
    1 Other