BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 21332829 · Received February 7, 2025

    Report

    Report Number
    3023359743-2025-00089
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Report Date
    February 7, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH IS CONSIDERED BOTH AN INITIAL AND FINAL REPORT AS THE INVESTIGATION HAS BEEN COMPLETED. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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

    CALLER REPORTED ON BEHALF OF HER MOTHER (CONSUMER) THAT THE PATIENT END NEEDLES BEND DURING INJECTION. SHE ALSO STATED THAT THE PEN JAMS DURING INJECTION. CONSUMER DOES NOT RE-USE. CONSUMER DISCARDED THE BOX SO SHE WAS NOT ABLE TO PROVIDE THE PRODUCT # BUT STATED THAT SHE IS USING NANO PRO PEN NEEDLES. LOT #: 4051852, CATALOG #: UNKNOWN, DATE OF EVENT: UNKNOWN, SAMPLES: DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247306 UNKNOWN Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose