BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO INSULIN PEN NEEDLE

    MDR report key: 9145356 · Received October 2, 2019

    Report

    Report Number
    9616656-2019-00941
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    September 17, 2019
    Report Date
    November 6, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403897511
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE WAS RETURNED FROM LOT. NO. 9092812, CAT. NO. 320883. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND IT WAS OBSERVED THAT THE PATIENT END OF THE CANNULA WAS BROKEN AND A HOLE IN THE SHIELD WAS ALSO OBSERVED. NO ISSUES WERE OBSERVED WITH THE NON PATIENT END OF THE CANNULA. 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 OF THIS ISSUE WAS INCORRECT LOADING OF THE SHIELD TO THE HUB AT THE SHIELDING STATION. CAPA 290556 WAS RAISED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONSUMER NOTICED THE BD ULTRA-FINE¿ NANO INSULIN PEN NEEDLE WAS BROKEN WHILE SCREWING IT ONTO THE INSULIN PEN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER I TOOK OFF THE PAPER COVER, I WAS SCREWING THE BD NEEDLE ONTO MY LEVIMIR INSULIN PEN AND NOTICED THE NEEDLE WAS BROKEN."

    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 THAT THE CONSUMER NOTICED THE BD ULTRA-FINE¿ NANO INSULIN PEN NEEDLE WAS BROKEN WHILE SCREWING IT ONTO THE INSULIN PEN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER I TOOK OFF THE PAPER COVER, I WAS SCREWING THE BD NEEDLE ONTO MY LEVIMIR INSULIN PEN AND NOTICED THE NEEDLE WAS BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942575 BD ULTRA-FINE¿ NANO INSULIN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9092812 10885403897511

    Patients

    Seq Age Sex Outcome Treatment
    1 Other