BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX FR

    MDR report key: 21019547 · Received December 26, 2024

    Report

    Report Number
    3023359743-2024-00800
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Report Date
    March 11, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 AS AGREED BY PHONE, HERE IS THE EMAIL SUMMARIZING THE PROBLEM. BOX CONCERNED: BD MICRO-FINE ULTRA PRO 4MM NEEDLES. CODE:320562 / (B)(4). EVEN AFTER PURGING, THE LIQUID DOES NOT COME OUT ON A LITTLE MORE THAN HALF OF THE NEEDLES WITH THE PATIENT'S TRESIBA FLEXTOUCH PEN, AS IF THE NEEDLE WAS CLOGGED AT THE END. THE PROBLEM APPEARED ON THE BOXES ISSUED ON (B)(6)2024. AFFECTED LOT: 414 9034 EXP 31/05/2029 AND 4079028 EXP 31/03/2029. FOR ANY FURTHER INFORMATION, THE PATIENT IS AVAILABLE ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495418 PEN NDL 32G 4MM PRO 100 BOX FR NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320562 4149034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown