BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM EU

    MDR report key: 20668369 · Received November 12, 2024

    Report

    Report Number
    3023359743-2024-00659
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 17, 2024
    Report Date
    November 12, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH REPORT IS BOTH AN INITIAL AND FINAL REPORT AS THE INVESTIGATION HAS BEEN COMPLETED. 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

    ONE OF OUR PATIENTS RETURNED TO THE PHARMACY WITH A COMPLAINT ABOUT THE BD AUTOSHIELD DUO. 30G X 3/16¿ . NEEDLE GETS STUCK. TESTED ALMOST HALF A BOX, PROBLEM WITH EVERY PEN. LOT NUMBER 4032907. EXPIRATION DATE 28-02-2027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657976 PEN NEEDLE AUTOSHIELD DUO 30GX5MM EU Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 329605 4032907

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown