BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM EU

    MDR report key: 21159380 · Received January 15, 2025

    Report

    Report Number
    3023359743-2025-00050
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    December 29, 2024
    Report Date
    March 16, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    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: 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-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

    WHEN REMOVING THE BD AUTO SHIELD NEEDLE FROM THE SKIN AFTER ADMINISTERING THE INSULIN, PATIENT REPORTED JOYFULLY 'OH I NEVER FELT A THING'. I LOOKED CLOSER AT THE SKIN AND THERE SEEMED TO BE A SMALL, TINY POOL OF CLEAR FLUID FROM THIS. I THEN LOOKED AT THE BD AUTO SHIELD NEEDLE AND IT LOOKED AS IF THE NEEDLE HAD ONLY PARTIALLY RETRACTED? NOT EVER SEEN IT LIKE THIS BEFORE OR KNOWINGLY HAD THIS HAPPEN BEFORE. BD AUTO SHIELD NEEDLE BATCH: 4072074, 31/03/2027 DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583630 PEN NEEDLE AUTOSHIELD DUO 30GX5MM EU NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 329605 4072074

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female