BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO INSULIN PEN NEEDLE

    MDR report key: 12599031 · Received October 8, 2021

    Report

    Report Number
    9616656-2021-01253
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Date of Event
    September 12, 2021
    Report Date
    October 20, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUATION? YES. D10: RETURNED TO MANUFACTURER ON: 2021-10-08 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (2) OPEN 32GX4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS OR INNER SHIELDS ATTACHED. THE CONSUMER REPORTED NO INSULIN FLOW DURING PRIMING, AND REPORTED 1 PEN NEEDLE MISSING GREEN INNER SHIELD PRIOR TO USE. BOTH RETURNED PEN NEEDLES WERE EXAMINED, AND IT WAS OBSERVED THAT 1 EXHIBITED A BENT NON-PATIENT END (NPE) AND 1 EXHIBITED A BROKEN NPE CANNULA. NO INNER SHIELDS WERE RETURNED WITH EITHER SAMPLE. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON EITHER PEN NEEDLE. THE BENT AND BROKEN NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THAT THE PEN NEEDLES WERE CLOGGED. SINCE BOTH SAMPLES WERE RETURNED AFTER USE, THE PROBABLE CAUSE OF THE BENT AND BROKEN NPE CANNULAS IS USER RELATED. PEN NEEDLE DHR BATCH 0073556 WAS REVIEWED. THE BATCH NUMBER WAS BUILT WITH PEN NEEDLE ASSEMBLY LINE IN OCT 2020. REVIEW OF THE DHR REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. NO QUALITY NOTIFICATION WAS RAISED ON PAST 12 MONTHS ON SIMILAR NON-CONFORMANCE. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE (NPE CANNULA BENT, NPE CANNULA BROKEN) BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (MISSING INNER SHIELDS) THE ROOT CAUSE FOR THIS ISSUE IS USER RELATED. THE NPE CANNULAS WERE BENT AND BROKEN AFTER THE CUSTOMER HANDLED THE PEN NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD ULTRA-FINE¿ NANO INSULIN PEN NEEDLE EACH FROM LOTS 0073556 AND AN UNSPECIFIED LOT WERE BLOCKED AND WOULD NOT PRIME INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN I SAY THE NEEDLES DID NOT WORK PROPERLY, I AM TELLING YOU THAT THE INSULIN WAS NOT ABLE TO FLOW THROUGH THE NEEDLE WHEN I DID THE INITIAL CHECK. WHEN I REPLACE THE NEEDLE WITH ANOTHER ONE, IT WORKED FINE. THEREFORE IT WAS NOT THE INSULIN PEN. THIS HAS HAPPENED IN THE PAST OCCASIONALLY BUT NOW I FEEL IT IS HAPPENING ON A REGULAR BASIS.".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0073556. MEDICAL DEVICE EXPIRATION DATE: 2025-04-30. DEVICE MANUFACTURE DATE: 2020-03-13. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. UNKNOWN, (B)(6) HAS BEEN USED AS A DEFAULT. 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 · 1

    IT WAS REPORTED THAT 1 BD ULTRA-FINE¿ NANO INSULIN PEN NEEDLE EACH FROM LOTS 0073556 AND AN UNSPECIFIED LOT WERE BLOCKED AND WOULD NOT PRIME INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN I SAY THE NEEDLES DID NOT WORK PROPERLY, I AM TELLING YOU THAT THE INSULIN WAS NOT ABLE TO FLOW THROUGH THE NEEDLE WHEN I DID THE INITIAL CHECK. WHEN I REPLACE THE NEEDLE WITH ANOTHER ONE, IT WORKED FINE. THEREFORE IT WAS NOT THE INSULIN PEN. THIS HAS HAPPENED IN THE PAST OCCASIONALLY BUT NOW I FEEL IT IS HAPPENING ON A REGULAR BASIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493852 BD ULTRA-FINE¿ NANO INSULIN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown