BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA

    MDR report key: 21446990 · Received February 24, 2025

    Report

    Report Number
    3023359743-2025-00152
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    January 30, 2025
    Report Date
    February 24, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903295159
    PMA / PMN Number
    K223286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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

    ACCOUNT - XXXXX PHARMACY ITEM# 329515, LOT: 4073006, MFG: 3/31/24, EXP: 03/31/27. COMPLAINT - "I AM CONTACTING YOU DUE TO A SAFETY EVENT WE HAD WITH THE BD AUTOSHIELD DUO. ONE OF OUR NURSING STAFF WAS ADMINISTERING INSULIN TO A PATIENT AND WHEN SHE WENT TO TAKE OFF THE ATTACHED NEEDLE AFTER GIVING THE INSULIN, PART OF THE NEEDLE REMAINED IN THE PEN. THE SAFETY ACTION ON THE TOP OF THE NEEDLE APPEARS TO HAVE FUNCTIONED PROPERLY, BUT PART OF THE NEEDLE BROKE OFF AND REMAINED IN THE PEN. "X

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613129 PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 329515 4073006 00382903295159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose