BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 6MM 3B TW 70CT JPN

    MDR report key: 10840854 · Received November 13, 2020

    Report

    Report Number
    9616656-2020-01138
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 21, 2020
    Report Date
    February 26, 2021
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 11/4/2020. H.6. INVESTIGATION: TWO OPEN 32G X 6MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 9121516, CAT. NO. 320738. A CLOG TESTING AS PER TP700483 WAS CARRIED OUT ON THE RETURNED SAMPLES AND NO ISSUE WAS 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 SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 32G 6MM 3B TW 70CT JPN WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED ABOUT NEEDLE CLOG."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEN NDL 32G 6MM 3B TW 70CT JPN WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED ABOUT NEEDLE CLOG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305374 PEN NDL 32G 6MM 3B TW 70CT JPN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9121516

    Patients

    Seq Age Sex Outcome Treatment
    1