BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO PEN NEEDLE

    MDR report key: 17769846 · Received September 18, 2023

    Report

    Report Number
    9616656-2023-01005
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    August 31, 2023
    Report Date
    October 19, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    H.3. 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 AUTOSHIELD¿ DUO PEN NEEDLE HAD A LABEL WITH A DIFFERENT EAN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST INFORMED US THAT SKU 329917 HAS GOT A YELLOW LABEL AS SKU 329916 WITH PZN 15320176 BUT DIFFERENT EAN. VERY DIFFICULT TO DISTINGUISH

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD AUTOSHIELD¿ DUO PEN NEEDLE HAD A LABEL WITH A DIFFERENT EAN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST INFORMED US THAT SKU 329917 HAS GOT A YELLOW LABEL AS SKU 329916 WITH PZN 15320176 BUT DIFFERENT EAN. VERY DIFFICULT TO DISTINGUISH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781971 BD AUTOSHIELD¿ DUO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 3010167

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown