BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 29GA 12.7MM 100 BX 1200 USA

    MDR report key: 21914996 · Received April 25, 2025

    Report

    Report Number
    3023359743-2025-00311
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Report Date
    April 25, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903282036
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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-CONFORMANCE'S 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 IS REPORTING "NEEDLE BREAK" WHEN TAKING INJECTIONS, (THE PATIENT END) STATED, WITH MOST OF THE BOXES HE'S RECEIVED IN THE LAST TWO YEARS, HE HAS EXPERIENCED THE ISSUE, (COULD NOT PROVIDE LOT OR HOW MANY BOXES HAVE BEEN USED FOR THE LAST TWO YEARS). STATED, HE IS ABLE TO REMOVE THE NEEDLES FROM HIS BODY WHEN THEY BREAK OFF. STATED, HE DOES NOT RE-USE AND ROTATES THE DIFFERENT INJECTION SITES, STATED, HE HAS BEEN USING THE PRODUCT FOR OVER 40 YEARS AND NEVER HAD ANY PROBLEMS UNTIL 2 YEARS AGO. THIS IS THE FIRST TIME THE CONSUMER IS CALLING IN TO REPORT THE PROBLEM. STATED, THE QUALITY HAS GONE DOWN WITH THE PRODUCT AND THE NEEDLES ARE TOO THIN. STATED, NO INJURY TO REPORT, LOT: 2123114, CATALOG: 328203, DATE OF EVENT: UNKNOWN, SAMPLES: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370756 PEN NDL 29GA 12.7MM 100 BX 1200 USA Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 328203 2123114 00382903282036

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male