BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PEN NEEDLE 32G X 4MM

    MDR report key: 6949877 · Received October 13, 2017

    Report

    Report Number
    9616656-2017-00112
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    September 19, 2017
    Report Date
    November 7, 2017
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE 32G X 4MM PEN NEEDLE SAMPLE AND FOUR PHOTOS WERE RETURNED FROM LOT. NO. 6140853, CAT. NO. 320136. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND PHOTOS AND IT WAS OBSERVED THAT THERE WAS BLACK MARKS ON SHIELD. INVESTIGATION CONCLUSION: VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND PHOTOS AND IT WAS OBSERVED THAT THERE WAS BLACK MARKS ON SHIELD. ROOT CAUSE DESCRIPTION: THE MOST PROBABLE ROOT CAUSE WAS IDENTIFIED AS INCORRECT MOLDING START UP.

    Additional Manufacturer Narrative · 1

    RESULTS: 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. CONCLUSION: A CONCLUSION IS NOT YET AVAILABLE AS THE INVESTIGATION IS STILL IN PROGRESS. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS FOUND ON THE PATIENT END OF THE NEEDLE IN A FULL CARTON OF BD¿ PEN NEEDLE 32G X 4MM BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729258 BD¿ PEN NEEDLE 32G X 4MM INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 6140853

    Patients

    Seq Age Sex Outcome Treatment
    1 Other