BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA

    MDR report key: 22177905 · Received June 10, 2025

    Report

    Report Number
    3023359743-2025-00407
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 16, 2025
    Report Date
    June 10, 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
    MD, US
    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-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 - (B)(6). SKU# 329515 LOT # 4193027 QUANTITY - UNKNOWN. COMPLAINT - YESTERDAY WE HAD TO PULL LOT NUMBERS 4193027 AND 4164021 FOR SAP # (B)(4) BECAUSE THERE WAS A SAFETY EVENT THAT OCCURRED WITH THE INSULIN NEEDLES. DURING THE EVENT IT WAS DISCOVERED THAT THE NEEDLES WERE NOT RETRACTING. THERE WERE SEVERAL NEEDLES TESTED AND ALL OF THEM SEEM TO BE DOING THE SAME EXACT THING. I WANTED TO INFORM YOU ALL SO THAT YOU CAN REACH OUT TO ANYONE WHO MAY BE IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633587 PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 329515 4193027 00382903295159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown