BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32GA 4MM 100 BX 1200 CA

    MDR report key: 11083162 · Received December 28, 2020

    Report

    Report Number
    9616656-2020-01294
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    November 30, 2020
    Report Date
    April 8, 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 PEN NDL 32GA 4MM 100 BX 1200 CA WOULD NOT ATTACH AND WAS DIFFICULT TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320144 BATCH NO: 0022829. IT WAS REPORTED THAT SOME NEEDLES WILL NOT ATTACH TO THE INSULIN PEN AND THE INSULIN WHEN NOT FLOW WHEN PRIMING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEN NDL 32GA 4MM 100 BX 1200 CA WOULD NOT ATTACH AND WAS DIFFICULT TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320144, BATCH NO: 0022829. IT WAS REPORTED THAT SOME NEEDLES WILL NOT ATTACH TO THE INSULIN PEN AND THE INSULIN WHEN NOT FLOW WHEN PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545791 PEN NDL 32GA 4MM 100 BX 1200 CA PEN NEEDLE FMI BECTON DICKINSON AND CO. 0022829

    Patients

    Seq Age Sex Outcome Treatment
    1