BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE NANO INSULIN PEN NEEDLE

    MDR report key: 11060496 · Received December 22, 2020

    Report

    Report Number
    9616656-2020-01280
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    November 23, 2020
    Report Date
    March 3, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXPIRATION DATE WAS MISSING FROM THE BD ULTRA-FINE¿ NANO INSULIN PEN NEEDLE LABEL, AND THE LOT NUMBER WAS USED TO DETERMINE THAT IT HAD EXPIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CHECKING ON PEN NEEDLES FOUND FROM 2013 IN HER HOME. INFORMED THEY ARE EXPIRED AND TO DESTROY THEM. DETERMINED THEY EXPIRED FROM THE LOT NUMBER PROVIDED 3120247."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXPIRATION DATE WAS MISSING FROM THE BD ULTRA-FINE¿ NANO INSULIN PEN NEEDLE LABEL, AND THE LOT NUMBER WAS USED TO DETERMINE THAT IT HAD EXPIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CHECKING ON PEN NEEDLES FOUND FROM 2013 IN HER HOME. INFORMED THEY ARE EXPIRED AND TO DESTROY THEM. DETERMINED THEY EXPIRED FROM THE LOT NUMBER PROVIDED 3120247"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523747 BD ULTRA-FINE NANO INSULIN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 3120247

    Patients

    Seq Age Sex Outcome Treatment
    1