BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES

    MDR report key: 14737272 · Received June 17, 2022

    Report

    Report Number
    9616656-2022-00643
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    May 19, 2022
    Report Date
    July 20, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES THAT PEN NEEDLES WILL NOT ATTACH TO INSULIN PENS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: -CONSUMER REPORTED WHEN ATTACHING THESE 2ND GEN PEN NEEDLES TO MY NOVOLOG PEN AND LANTUS PENS THE THREADING CROSSES AND WILL NOT SCREW ONTO THE PEN. LOT # 1012829 = 1 BOX CATALOG# 320550 = 1 BOX DATE OF EVENT UNKNOWN THIS BOX IS 1 OUT OF 5 SUPPLIED AND ONLY ONE OPENED BOX SAMPLE STATUS AWAITING SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES THAT PEN NEEDLES WILL NOT ATTACH TO INSULIN PENS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: -CONSUMER REPORTED WHEN ATTACHING THESE 2ND GEN PEN NEEDLES TO MY NOVOLOG PEN AND LANTUS PENS THE THREADING CROSSES AND WILL NOT SCREW ONTO THE PEN. LOT # 1012829 = 1 BOX CATALOG# 320550 = 1 BOX DATE OF EVENT UNKNOWN THIS BOX IS 1 OUT OF 5 SUPPLIED AND ONLY ONE OPENED BOX SAMPLE STATUS AWAITING SAMPLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194099 BD NANO¿ 2ND GEN PEN NEEDLES HYPODERMIC NEEDLE FMI BECTON DICKINSON AND CO. 320550 1012829 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown