BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES 4MM X 32G

    MDR report key: 15722525 · Received November 3, 2022

    Report

    Report Number
    9616656-2022-01195
    Event Type
    Malfunction
    Date Received
    November 3, 2022
    Date of Event
    October 11, 2022
    Report Date
    November 17, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1221371. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 20 OF THE BD NANO¿ 2ND GEN PEN NEEDLES 4MM X 32G CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 20 PEN NEEDLES THAT CLOGGED DURING FLOW CHECK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 20 OF THE BD NANO¿ 2ND GEN PEN NEEDLES 4MM X 32G CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 20 PEN NEEDLES THAT CLOGGED DURING FLOW CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2789058 BD NANO¿ 2ND GEN PEN NEEDLES 4MM X 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 2054698 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown