BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 CA

    MDR report key: 19725211 · Received July 11, 2024

    Report

    Report Number
    3023359743-2024-00284
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Report Date
    September 30, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN B4, G6, H2, H11. CORRECTION MADE TO H6 (INVESTIGATION TYPE, INVESTIGATION CONCLUSION) 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

    CONSUMER REPORTED ON VOICE MESSAGE AND OUR CALL BACK FINDING THE PEN NEEDLE TO CLOG DURING THE INJECTION. INFORMED CALLER OF PROPER NON PATIENT END PLACEMENT AND TO COMPLETE A FLOW CHECK. DC LOT # 3241359, CATALOG# 320555, DATE OF EVENT UNKNOWN, SAMPLE STATUS DISCARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385267 PEN NDL 32G 4MM PRO 100 BOX 1200 CA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320555 3241359

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose