BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLE

    MDR report key: 13965936 · Received March 31, 2022

    Report

    Report Number
    9616656-2022-00351
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 11, 2022
    Report Date
    April 11, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    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. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 25-APR-2022. H.6. INVESTIGATION: CUSTOMER RETURNED A TOTAL OF 5 UNUSED 4MM, 32 GAUGE PEN NEEDLES FROM LOT 1173074. ALL OF THE PEN NEEDLES WERE INSPECTED AND NO DEFECTS WERE FOUND. EACH OF THE PEN NEEDLES WERE ATTACHED TO A TEST PEN. SALINE WAS PUSHED THROUGH THE SYSTEM AND OUT THE DISTAL TIP OF THE PEN NEEDLES. ALL PEN NEEDLES FUNCTIONED AS INTENDED. UPON REMOVING THE PEN NEEDLES, THERE WAS NO DAMAGE OR BREAKAGES FOUND TO THE PROXIMAL END OF THE PEN NEEDLES. 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. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST ONE BD NANO¿ 2ND GEN PEN NEEDLE WAS UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATES, SOMETIMES NO INSULIN FLOW WHEN PRIMING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST ONE BD NANO¿ 2ND GEN PEN NEEDLE WAS UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATES, SOMETIMES NO INSULIN FLOW WHEN PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872573 BD NANO¿ 2ND GEN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 1173074 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown