BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ ULTRA FINE¿ PEN NEEDLE

    MDR report key: 17949607 · Received October 17, 2023

    Report

    Report Number
    9616656-2023-01116
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    October 13, 2023
    Report Date
    November 16, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    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 HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 03-NOV-2023. H.6. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AS BENT NPE CANNULA AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NANO¿ ULTRA FINE¿ PEN NEEDLE CLOGGED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED BD NANO, 32G PEN NEEDLES RECEIVED IN A BAG LOT # 2152906 FINDING 7-8 PEN NEEDLES CLOGGED DURING USE. CALLED LILLY FIRST USING THE KWIK PEN, HUMALOG. INFORMED CALLER OF PROPER PLACEMENT OF NON PATIENT END NEEDLE TO PEN AND TO COMPLETE FLOW CHECK WITH ALL INJECTIONS LOT # 2152906. CATALOG# RECEIVED ITEMS IN A BAG, NON MANUFACTURE BAG FROM LOCAL PHARMACY. NO ITEM # DATE OF EVENT (B)(6) 2023 = 1 PEN NEEDLE WITH THIS LOT # FROM TAB = AWAITING SAMPLE . DATE OF EVENT UNKNOWN = 6 PEN NEEDLES".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 BD NANO¿ ULTRA FINE¿ PEN NEEDLES CLOGGED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED BD NANO, 32G PEN NEEDLES RECEIVED IN A BAG LOT # 2152906 FINDING 7-8 PEN NEEDLES CLOGGED DURING USE. CALLED LILLY FIRST USING THE KWIK PEN, HUMALOG. INFORMED CALLER OF PROPER PLACEMENT OF NON PATIENT END NEEDLE TO PEN AND TO COMPLETE FLOW CHECK WITH ALL INJECTIONS LOT # 2152906 CATALOG# RECEIVED ITEMS IN A BAG, NON MANUFACTURE BAG FROM LOCAL PHARMACY. NO ITEM # DATE OF EVENT 10/13/2023 = 1 PEN NEEDLE WITH THIS LOT # FROM TAB = AWAITING SAMPLE DATE OF EVENT UNKNOWN = 6 PEN NEEDLES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1631192 BD NANO¿ ULTRA FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2153906 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown