BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM

    MDR report key: 21241812 · Received January 27, 2025

    Report

    Report Number
    3023359743-2025-00068
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    January 6, 2025
    Report Date
    March 24, 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: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. 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. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Additional Manufacturer Narrative · 0

    2 PEN NEEDLES IMPACTED FROM LOT # 4072045. SEE SECTION C FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    PICK UP THE PRODUCT AND PREPARE TO OPEN IT,THERE ARE MANY UNKNOWN BLACK SPOTS ON THE UNOPENED PRODUCT PACKAGING .#329505,2 EA, LOT 4072045

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534463 PEN NEEDLE AUTOSHIELD DUO 30GX5MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 329505 4072045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female