BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES

    MDR report key: 16882198 · Received May 5, 2023

    Report

    Report Number
    9616656-2023-00446
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 14, 2023
    Report Date
    May 25, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 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.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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 · 0

    IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLES TEAR DROP LABEL WAS MISSING. THIS IS 2 OF 2 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 2 PEN NEEDLES MISSING THE PAPER TEAR TAB ON NON PATIENT END OF NEEDLE LOT # 2200709 . CATALOG# 320550. DATE OF EVENT 04/14/2023 = 1 PEN NEEDLE. DATE OF EVENT UNKNOWN = 1 PEN NEEDLE LAST WEEK. SAMPLE STATUS AWAITING SAMPLE = 2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLES TEAR DROP LABEL WAS MISSING. THIS IS 2 OF 2 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 2 PEN NEEDLES MISSING THE PAPER TEAR TAB ON NON PATIENT END OF NEEDLE LOT # 2200709, CATALOG# 320550, DATE OF EVENT 04/14/2023 = 1 PEN NEEDLE, DATE OF EVENT UNKNOWN = 1 PEN NEEDLE LAST WEEK, SAMPLE STATUS AWAITING SAMPLE = 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692928 BD NANO¿ 2ND GEN PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 2200709 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown