BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY

    MDR report key: 22124761 · Received June 2, 2025

    Report

    Report Number
    3023359743-2025-00395
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Report Date
    June 2, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 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. 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

    THE CONSUMER REPORTED PEN NEEDLE CLOG WHEN TAKING INJECTIONS. 25-30 PEN NEEDLE AFFECTED FROM ONE BOX PER CONSUMER. DOES NOT PRIME BEFORE INJECTIONS BUT WILL GOING FORWARD. LOT: 4240146 CATALOG: 320883 DATE OF EVENT: UNKNOWN SAMPLES: YES CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478397 PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320883 4240146

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown