BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP

    MDR report key: 11417720 · Received March 4, 2021

    Report

    Report Number
    9616656-2021-00214
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    December 17, 2020
    Report Date
    March 19, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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 PEN NDL 32G 4MM HP WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320144, BATCH NO: 9072616. CONSUMER REPORTED WHEN INJECTING THEY WILL NOT PRESS OUT INSULIN WITH DIFFERENT BOXES. INFORMED NON PATIENT END PLACEMENT.

    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 THAT THE PEN NDL 32G 4MM HP WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320144, BATCH NO: 9072616. CONSUMER REPORTED WHEN INJECTING THEY WILL NOT PRESS OUT INSULIN WITH DIFFERENT BOXES. INFORMED NON PATIENT END PLACEMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312537 PEN NDL 32G 4MM HP PEN NEEDLE FMI BECTON DICKINSON AND CO. 9072616

    Patients

    Seq Age Sex Outcome Treatment
    1