BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    MDR report key: 20812315 · Received November 29, 2024

    Report

    Report Number
    3023359743-2024-00714
    Event Type
    Malfunction
    Date Received
    November 29, 2024
    Report Date
    February 19, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE 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

    CONSUMER REPORTED FINDING THE NEEDLES TO POCKET THE INSULIN UNDER THE SKIN. DOES NOT PINCH UP THE SKIN. COMPLETES A FLOW CHECK. CONSUMER REPORTED FINDING A FEW TO CLOG DURING INJECTION BUT NOT THE FLOW CHECK. CONSUMER REPORTED 1 ADDITIONAL PEN NEEDLE FROM THIS BOX GAVE HER A BRUISE. LOT # 4030414. CATALOG# 320550. DATE OF EVENT UNKNOWN. SAMPLE STATUS AWAITING SAMPLE UNUSED FROM THIS BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2618961 PEN NDL 32G 4MM PRO 100 BOX 1200 US NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320550 4030414 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female