BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 90CT US

    MDR report key: 22044682 · Received May 19, 2025

    Report

    Report Number
    3023359743-2025-00369
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    April 24, 2025
    Report Date
    May 19, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903205745
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH SUBMISSION IS BOTH AN INITIAL AND SUPPLEMENTAL FILING. INVESTIGATION OF THE RESULTS CAN BE SEEN BELOW: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 3RD 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED FOUND 4 PEN NEEDLES FROM THIS BOX TO CLOG DURING THE FLOW CHECK. DISCARDED 3 OF THE 4. HAS 1 PEN NEEDLE FROM TODAYS INJECTION TO SEND BACK. REVIEWED WITH THIS CALLER PROPER PLACEMENT OF NON-PATIENT END TO PEN, HE NOTED THE NON-PATIENT END NEEDLE TO BE BENT. (THIS IS THE ONE RETURNING) DATE OF EVENT 04.25.2025). LOT # 310174, CATALOG# 320574, DATE OF EVENT 04.25.2025 = 1, DATE OF EVENT UNKNOWN = 3, SAMPLE STATUS AWAITING SAMPLE = 1. TMAIK 24APRIL2025. CLARIFICATION. UPDATE 00024018, DATE OF EVENT IS 04.24.2025 = 1 PEN NEEDLE, LOT # 3101704.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158229 PEN NDL 32G 4MM PRO 90CT US Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320574 3101704 00382903205745

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown