BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 105 BOX DE

    MDR report key: 22922696 · Received August 29, 2025

    Report

    Report Number
    3023359743-2025-00466
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Report Date
    August 29, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    "WE HAVE RECEIVED A CUSTOMER COMPLAINT REGARDING YOUR PRODUCT BD ULTRA-FINE PRO PEN NEEDLES PZN 14046738 CH.REF.: 4282236. A CUSTOMER HAS BEEN USING THE NEEDLES FOR 1 YEAR. THE NEEDLES ¿DO NOT GO UNDER THE SKIN¿ AND ARE ¿CLOGGED¿, MEANING THAT NO INSULIN IS DELIVERED. THIS HAS ALREADY OCCURRED IN SEVERAL PACKS WITH INDIVIDUAL NEEDLES. AS A RESULT, THE CUSTOMER HAS ALREADY HAD TO PURCHASE ANOTHER PACK PRIVATELY. WE HAVE A SAMPLE PACK AVAILABLE. DO YOU KNOW WHAT MIGHT HAVE CAUSED THIS PROBLEM AND HOW IT COULD BE RESOLVED?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024912 PEN NDL 32G 4MM PRO 105 BOX DE Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320561 4282236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown