BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES

    MDR report key: 17410135 · Received July 27, 2023

    Report

    Report Number
    9616656-2023-00786
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    July 6, 2023
    Report Date
    October 12, 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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 04-AUG-2023. H6: INVESTIGATION SUMMARY THE CUSTOMER RETURNED (2) OPEN 32G 4MM PEN NEEDLES FROM LOT#2242759, REPORTING NEEDLE CLOG. THE PEN NEEDLES WERE VISUALLY INSPECTED AND OBSERVED (1) PEN NEEDLE WITH BENT CANNULA NPE AND NO ISSUES ON THE (2) PEN NEEDLE. A FUNCTIONALITY CLOG TEST WAS PERFORMED ON THE (2) SAMPLE AND OBSERVED PROPER FLOW OF FLUID. MOST LIKELY THE CUSTOMER'S REPORTED FAILURE OCCURRED DUE TO A BENT NPE CANNULA. THE ROOT CAUSE CANNOT BE DETERMINED AS THE RETURN SAMPLES WERE OPENED. BASED ON THE SAMPLE RETURNED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER-INDICATED FAILURE AS A BENT CANNULA NPE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRIMING WITH BD NANO¿ 2ND GEN PEN NEEDLES INSULIN DID NOT FLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE CLOG DURING PRIMING, STATED THAT THERE IS NO INSULIN FLOW. CONSUMER DOES NOT RE-USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRIMING WITH BD NANO¿ 2ND GEN PEN NEEDLES INSULIN DID NOT FLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE CLOG DURING PRIMING, STATED THAT THERE IS NO INSULIN FLOW. CONSUMER DOES NOT RE-USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755784 BD NANO¿ 2ND GEN PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2242759 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown