BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM

    MDR report key: 11917431 · Received June 1, 2021

    Report

    Report Number
    9616656-2021-00615
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 6, 2021
    Report Date
    June 2, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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: 5/24/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (6) USED 32GX4MM BD PEN NEEDLES FROM LOT# 0134225. CONSUMER STATED, ITS HARD TO REMOVE PEN NEEDLE AFTER INJECTION. ALL 6 RETURNED SAMPLES WERE EXAMINED, THEN TESTED FOR FUNCTIONALITY USING A TEST PEN INJECTOR: ALL 6 PEN NEEDLES WERE ABLE TO ATTACH TO/DETACH FROM THE PEN INJECTOR PROPERLY. NO DEFECTS 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD PEN NDL 32G 4MM WOULD NOT DETACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:   THE CONSUMER REPORTED IT HARD TO REMOVE THE PEN NEEDLE AFTER INJECTION. DATE OF EVENT: UNKNOWN. SAMPLES: YES.

    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 1 BD PEN NDL 32G 4MM WOULD NOT DETACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : ¿ THE CONSUMER REPORTED IT HARD TO REMOVE THE PEN NEEDLE AFTER INJECTION. DATE OF EVENT: UNKNOWN. SAMPLES: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813441 PEN NDL 32G 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 0134225 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1