BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ MINI PEN NEEDLES

    MDR report key: 17159964 · Received June 19, 2023

    Report

    Report Number
    9616656-2023-00606
    Event Type
    Malfunction
    Date Received
    June 19, 2023
    Date of Event
    May 24, 2023
    Report Date
    July 6, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4 DEVICE EXPIRATION DATE: NA. E.1. THE CUSTOMER'S ADDRESS IS UNKNOWN. UNKNOWN, (B)(6) , 00000 USA HAS BEEN USED AS A DEFAULT. 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 ULTRA-FINE¿ MINI PEN NEEDLES HAD NO EXPIRATION DATE ON THE BOX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CONSUMER CALLED TO INQUIRE ABOUT PEN NEEDLE EXPIRATION, STATED THAT THERE IS NO DATE ON THE BOX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ MINI PEN NEEDLES HAD NO EXPIRATION DATE ON THE BOX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CONSUMER CALLED TO INQUIRE ABOUT PEN NEEDLE EXPIRATION, STATED THAT THERE IS NO DATE ON THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545534 IT WAS REPORTED THAT THE BD ULTRA-FINE¿ MINI PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 7248710

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown