BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO

    MDR report key: 9767815 · Received February 28, 2020

    Report

    Report Number
    9616656-2020-00164
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    February 6, 2020
    Report Date
    March 12, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NINETY FIVE SEALED 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 9092806, CAT. NO. 320566. A CLOG TEST WAS CARRIED OUT ON ALL NINETY FIVE SAMPLES AS PER TP700483 AND NO ISSUES WERE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO ISSUES WERE OBSERVED ON THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 PEN NDLS 32G 4MM PRO EXPERIENCED AN INABILITY TO DELIVER INSULIN/MEDICATION PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED NEEDLE APPEARED BLOCKED. CUSTOMER RETURNED TO POINT OF SALE AND REPORTED NEEDLE APPEARED BLOCKED. DIALED UP 2 UNITS FOR PRIME AND INSULIN DID NOT COME OUT OF PEN .PHARMACIST/CDE ALSO TRIED WITH 7 PN AND 6 WERE BLOCKED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10 PEN NDLS 32G 4MM PRO EXPERIENCED AN INABILITY TO DELIVER INSULIN/MEDICATION PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED NEEDLE APPEARED BLOCKED. CUSTOMER RETURNED TO POINT OF SALE AND REPORTED NEEDLE APPEARED BLOCKED. DIALED UP 2 UNITS FOR PRIME AND INSULIN DID NOT COME OUT OF PEN .PHARMACIST/CDE ALSO TRIED WITH 7 PN AND 6 WERE BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235595 PEN NDL 32G 4MM PRO PEN NEEDLE FMI BECTON DICKINSON AND CO. 9092806

    Patients

    Seq Age Sex Outcome Treatment
    1 Other