BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLE

    MDR report key: 17430851 · Received July 31, 2023

    Report

    Report Number
    9616656-2023-00799
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Date of Event
    July 7, 2023
    Report Date
    October 12, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    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

    H3. 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: 28-AUG-2023. H6: INVESTIGATION SUMMARY THE CUSTOMER RETURNED (10) OPEN 32G 4MM PEN NEEDLES FROM LOT#2242759, REPORTING NEEDLE CLOG. THE PEN NEEDLES WERE VISUALLY INSPECTED AND OBSERVED (5) PEN NEEDLES WITH BENT CANNULA NPE, (4) NEEDLES WITH BROKEN CANNULA NPE, AND NO ISSUES ON (1) PEN NEEDLE. A FUNCTIONALITY CLOG TEST WAS PERFORMED ON THE (1) SAMPLE AND OBSERVED THE PROPER FLOW OF FLUID. MOST LIKELY THE CUSTOMER'S REPORTED FAILURE OCCURRED DUE TO A BENT AND BROKEN 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 AND BROKEN 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. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER-INDICATED FAILURE AS A BENT AND BROKEN CANNULA NPE. THE ROOT CAUSE CANNOT BE DETERMINED, AS THE RETURNED SAMPLES WERE OPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF BD NANO¿ 2ND GEN PEN NEEDLES WERE NOT WORKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNFORTUNATELY, I HAVE NOT BEEN ABLE TO USE ALL OF THEM AS A NUMBER OF THEM DON'T WORK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF BD NANO¿ 2ND GEN PEN NEEDLES WERE NOT WORKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNFORTUNATELY, I HAVE NOT BEEN ABLE TO USE ALL OF THEM AS A NUMBER OF THEM DON'T WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811683 BD NANO¿ 2ND GEN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2292497 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown