BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE PLUS¿ PEN NEEDLE

    MDR report key: 9900557 · Received March 30, 2020

    Report

    Report Number
    9616656-2020-00273
    Event Type
    Malfunction
    Date Received
    March 30, 2020
    Date of Event
    March 9, 2020
    Report Date
    April 14, 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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE AND TWO PHOTOS WERE RETURNED FROM LOT. NO. 9162526, CAT. NO.320136. CLOG TESTING WAS CARRIED OUT ON THE ONE OPEN 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 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. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICRO-FINE PLUS¿ PEN NEEDLE WAS UNABLE TO DELIVER MEDICATION. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DRUG WAS HARD TO COME OUT.

    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 BD MICRO-FINE PLUS¿ PEN NEEDLE WAS UNABLE TO DELIVER MEDICATION. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DRUG WAS HARD TO COME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365287 BD MICRO-FINE PLUS¿ PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 9162526

    Patients

    Seq Age Sex Outcome Treatment
    1 Other