BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLE

    MDR report key: 15848094 · Received November 22, 2022

    Report

    Report Number
    9616656-2022-01277
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Date of Event
    October 31, 2022
    Report Date
    February 6, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 03-JAN-2023. INVESTIGATION SUMMARY CUSTOMER RETURNED A TOTAL OF 91 USED 4MM, 32 GAUGE NANO PRO PEN NEEDLES FROM LOT 2103194. THE PEN NEEDLES WERE VISUALLY INSPECTED PRIOR TO TESTING AND NO DEFECTS WERE OBSERVED. 30 OF THE PEN NEEDLES WERE ATTACHED TO A TEST PEN. SALINE WAS PUSHED THROUGH THE SYSTEM AND OUT THE DISTAL TIP OF EACH OF THE TEST PENS. THE RETURNED PEN NEEDLES WERE UNDAMAGED AND FUNCTIONED AS INTENDED. 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. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE CLOGS. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT 7 OF THE BD NANO¿ 2ND GEN PEN NEEDLE EXPERIENCED NO INSULIN FLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER CALLED BACK AND PROVIDED PRODUCT #. CONSUMER REPORTED WHEN PRIMING, NO INSULIN FLOWS STATED, WHEN ADMINISTERING INJECTION TO HER MINOR CHILD, NO INSULIN FLOWED STATED, MINOR CHILD WAS JUST DIAGNOSED WITH TYPE 1 STATED, IT'S FRUSTRATING HAVING TO STICK HIM MORE THAN NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT 7 OF THE BD NANO¿ 2ND GEN PEN NEEDLE EXPERIENCED NO INSULIN FLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER CALLED BACK AND PROVIDED PRODUCT #. CONSUMER REPORTED WHEN PRIMING, NO INSULIN FLOWS STATED, WHEN ADMINISTERING INJECTION TO HER MINOR CHILD, NO INSULIN FLOWED STATED, MINOR CHILD WAS JUST DIAGNOSED WITH TYPE 1 STATED, IT'S FRUSTRATING HAVING TO STICK HIM MORE THAN NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247607 BD NANO¿ 2ND GEN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 2103194 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown