BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX8MM EU

    MDR report key: 22307887 · Received June 23, 2025

    Report

    Report Number
    3023359743-2025-00423
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Report Date
    June 23, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    DEAR SIR OR MADAM, PLEASE FIND ATTACHED A REPORT OF MATERIAL VIGILANCE SENT BY OUR CLIENT (B)(6), CONCERNING THE AUTOSHIELD DUO INSULIN PEN NEEDLE REFERENCE 329608 FROM BATCH 4072078. DESCRIPTION OF THE ENCOUNTERED PROBLEM: THE CLIENT HAS REPORTED SEVERAL MALFUNCTIONS, INCLUDING: A DEFECT IN THE NEEDLE RETRACTABILITY SYSTEM, THE INABILITY TO ADMINISTER THE DESIRED AMOUNT. MEASURES TAKEN BY THE CLIENT: AS A PRECAUTION, 8 BOXES OUT OF THE 12 ORDERED HAVE BEEN PUT IN QUARANTINE. IT IS LIKELY THAT THE REMAINING 4 HAVE ALREADY BEEN USED. THE CLIENT REQUESTS: A CREDIT NOTE, AS WELL AS THE RETURN OF THE REMAINING 8 BOXES. MEASURES TAKEN BY KÉLIS MEDICAL-APOTECNIA: HANDLING OF THE PRODUCT RETURN AS WELL AS THE ISSUANCE OF THE CREDIT NOTE. AFTER VERIFICATION, WE NO LONGER HAVE ANY STOCK AVAILABLE FOR THIS BATCH, WHICH WAS FULLY SOLD BETWEEN 03/14/2025 AND 05/20/2025. THE BATCH WAS RECEIVED IN OUR WAREHOUSE ON 01/15/2025, COMING FROM EMBECTA. WHILE WAITING FOR YOUR INVESTIGATION, THE BOXES PLACED IN QUARANTINE BY THE CLIENT ARE BEING TRANSPORTED TO OUR DEPOT IN ESCALQUENS (31) AND REMAIN AT YOUR DISPOSAL FOR ANY FURTHER ANALYSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754863 PEN NEEDLE AUTOSHIELD DUO 30GX8MM EU Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 329608 4072078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown