BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO FINE PLUS INSULIN PEN NEEDLE

    MDR report key: 10171254 · Received June 18, 2020

    Report

    Report Number
    9616656-2020-00562
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 28, 2020
    Report Date
    July 9, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE AND THREE PHOTOS WERE RETURNED FROM LOT. NO. 9162526, CAT. NO. 320136. A CLOG TEST WAS CARRIED OUT ON THE RETURNED SAMPLE AS PER TP700483 AND NO ISSUES WERE 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLE OR PHOTOS THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THE BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE WAS UNABLE OR DIFFICULT TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER NOTICED THE " DRUG DIDN'T COME OUT UPON AIR PURGE.¿

    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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE THE BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE WAS UNABLE OR DIFFICULT TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER NOTICED THE " DRUG DIDN'T COME OUT UPON AIR PURGE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636009 BD MICRO FINE PLUS INSULIN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9162526

    Patients

    Seq Age Sex Outcome Treatment
    1 Other