BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 31G 5MM XTW 5B 7PACK

    MDR report key: 24273152 · Received February 5, 2026

    Report

    Report Number
    3027605735-2026-00006
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 9, 2026
    Report Date
    February 20, 2026
    Manufacturer
    EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE INVESTIGATION IS CURRENTLY IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A DETAILED SUMMARY WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H11. CORRECTION TO: H6 (COMPONENT CODE, TYPE OF INVESTIGATION AND INVESTIGATION FINDINGS). INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED, INVESTIGATION WAS PERFORMED ON RETAIN SAMPLES AND NO ISSUES WERE OBSERVED, 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

    NEEDLE BROKE OFF DURING USE IN THE STOMACH, USED WITH MOUNJARO 2.5 MG KWIKPEN TMAIK 12JANUARY2026: CAT # ENTERED AS 32054559 WITH LOT 4180029.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334609 PEN NEEDLE 31G 5MM XTW 5B 7PACK NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA 320545 4180029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown