BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE

    MDR report key: 8364165 · Received February 22, 2019

    Report

    Report Number
    9616656-2019-00177
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    February 6, 2019
    Report Date
    March 21, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903251056
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: FOUR PHOTOS OF A 31G X 8MM PEN NEEDLE SAMPLE WERE RETURNED FROM LOT. NO. 8122822, CAT. NO. 325105. VISUAL EXAMINATION OF THE RETURNED PHOTOS WAS CARRIED OUT AND A CANNULA THROUGH SHIELD AND COVER WAS OBSERVED. 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. ROOT CAUSE: ROOT CAUSE OF THIS ISSUE WAS INCORRECT LOADING OF THE SHIELD TO THE HUB AT THE SHIELDING STATION. CAPA (B)(4) WAS RAISED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE WENT THROUGH OUTER SHIELD AND HAD STERILITY ISSUES. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD MICRO-FINE ULTRA INSULIN PEN NEEDLE WENT THROUGH OUTER SHIELD AND HAD STERILITY ISSUES. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157792 BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 8122822 00382903251056

    Patients

    Seq Age Sex Outcome Treatment
    1 Other