BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM EU

    MDR report key: 24431979 · Received February 24, 2026

    Report

    Report Number
    3023359743-2026-00010
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    January 15, 2026
    Report Date
    February 24, 2026
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    EVENT DETAILS: DATE OF EVENT: 15 JANUARY 2026. DESCRIPTION: SAFETY NEEDLE WITH A FAULTY SAFETY SYSTEM. GLOVES WORN DURING NEEDLE REMOVAL, MINOR SKIN SCRATCH/INJURY. BLOODBORNE PATHOGEN EXPOSURE INCIDENT (IN FRENCH: ¿ACCIDETN EXPOSANT AU SANG¿ ¿ AES) PROCEDURE IMPLEMENTED. OCCUPATIONAL HEALTH SERVICES NOTIFIED. (A0510) (E2105). PATIENT RELATED INFORMATION: CURRENT STATE: NOTHING TO REPORT (E2403). ACTIONS TAKEN IN THE HEALTHCARE FACILITY FOR THE CARE OF THE PATIENT: BATCH NUMBER RECORDED, TRANSMISSIONS TO THE TEAMS. DEVICE NOT STORED. DEVICE SUBJECT OF THE EVENT: SKU: 329605. LOT NUMBER: 5183037. NAME: AUTOSHIELD DUO SAFETY PEN NEEDLE 0,30MM (30G) X 5MM. FOR REFERENCE, IMDRF CODES STATED IN THE REPORT FORM: E2403: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS ¿ NO PATIENT INVOLVEMENT OR, NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IS IDENTIFIED IN THE PATIENT. A0510: RETRACTION PROBLEM ¿ PROBLEM ASSOCIATED WITH DRAWING BACK THE DEVICE TO AN INTENDED LOCATION. E2105: EXPOSURE TO BODE FLUIDS ¿ EXPOSED TO OR CONTACTED WITH BLOOD OR BODY FLUIDS OF ANOTHER PERSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496320 PEN NEEDLE AUTOSHIELD DUO 30GX5MM EU Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 329605 5183037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown