BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ PEN NEEDLE

    MDR report key: 16251264 · Received January 26, 2023

    Report

    Report Number
    9616656-2023-00033
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 7, 2023
    Report Date
    February 3, 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2221273, MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2027, DEVICE MANUFACTURE DATE: 09-AUG-2022. MEDICAL DEVICE LOT #: 2159728, MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2027, DEVICE MANUFACTURE DATE: 08-JUN-2022. 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INFORMATIVE LEAFLET WAS MISSING FROM THE PACKAGE OF BD ULTRA-FINE¿ PEN NEEDLES. THIS OCCURRED WITH 4 PACKAGES EACH IN LOTS 2221273 AND 2159728. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "I WOULD ALSO LIKE TO POINT OUT THE ABSENCE OF THE LEAFLET WITH INFORMATION, WHICH WAS ALWAYS ENCLOSED IN THE PACKAGES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INFORMATIVE LEAFLET WAS MISSING FROM THE PACKAGE OF BD ULTRA-FINE¿ PEN NEEDLES. THIS OCCURRED WITH 4 PACKAGES EACH IN LOTS 2221273 AND 2159728. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "I WOULD ALSO LIKE TO POINT OUT THE ABSENCE OF THE LEAFLET WITH INFORMATION, WHICH WAS ALWAYS ENCLOSED IN THE PACKAGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470135 BD ULTRA-FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown