BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ PEN NEEDLE

    MDR report key: 8148024 · Received December 10, 2018

    Report

    Report Number
    9616656-2018-00289
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    November 20, 2018
    Report Date
    December 12, 2018
    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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR LEAKAGE & GLUCOSE LEVEL. THIS IS THE 2ND RELATED COMPLAINT FOR DOES NOT ATTACH/DETACH ON LOT # 8072768. THIS IS THE 1ST RELATED COMPLAINT FOR DIFFICULT/UNABLE TO OPERATE ON LOT # 8072768. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED INSULIN WAS LEAKING FROM THE BD NANO PEN NEEDLE DURING PRIMING, AND THERE WERE "BUBBLES IN THE PEN".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 INSULIN WAS LEAKING FROM THE BD NANO¿ PEN NEEDLE DURING PRIMING, AND THERE WERE "BUBBLES IN THE PEN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987356 BD NANO¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8072768 10885403897511

    Patients

    Seq Age Sex Outcome Treatment
    1 Other