BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 90CT US

    MDR report key: 19247571 · Received May 6, 2024

    Report

    Report Number
    3023359743-2024-00044
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Report Date
    July 29, 2024
    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
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED TO SECTIONS B4, G6, H2, H3, AND H11. CORRECTIONS MADE TO SECTIONS D3 (COUNTRY TYPE & COUNTRY) AND H6 (TYPE OF INVESTIGATION & INVESTIGATION CONCLUSIONS). INVESTIGATION SUMMARY: O 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 NEEDLE CLOG DURING PRIMING, STATED THAT THERE IS NO INSULIN FLOW. CONSUMER DOES NOT RE-USE. CONSUMER WAS NOT ABLE TO PROVIDE PRODUCT NUMBER, SHE STATED THAT THE PHARMACY LABEL WAS COVERING IT. SHE SAID SHE IS USING NANO 2ND GEN PEN NEEDLES PURCHASED THROUGH MAIL ORDER PHARMACY. LOT #: 3101704 CATALOG #: UNKNOWN DATE OF EVENT: UNKNOWN SAMPLES: AVAILABLE - SENDING MAIL KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613598 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