BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX FR

    MDR report key: 22358794 · Received June 30, 2025

    Report

    Report Number
    3023359743-2025-00429
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Report Date
    June 30, 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

    HELLO, WE HAVE BEEN CONTACTED BY MRS. (B)(6) REGARDING A PROBLEM ENCOUNTERED WITH A PURCHASED PRODUCT: (B)(6). THIS CONCERNS THE BD MICRO-FINE ULTRA PRO PEN NEEDLE 4MM, REFERENCE 320562, LOT 4010786, WITH AN EXPIRATION DATE OF JANUARY 31, 2029. MRS. (B)(6) REPORTED THAT THE PEN WAS BLOCKED AND THAT THE NEEDLE WAS CLOGGED, MAKING IT IMPOSSIBLE TO INJECT THE PRODUCT. THIS ISSUE OCCURRED TWICE IN THE SAME BOX. YOU CAN CONTACT MRS. (B)(6) DIRECTLY AT (B)(6) FOR ANY FURTHER INFORMATION. WE LOOK FORWARD TO HEARING FROM YOU, AND WE REMAIN, MADAM, SIR, WITH OUR BEST REGARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849357 PEN NDL 32G 4MM PRO 100 BOX FR Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320562 4010786

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown