BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    MDR report key: 19127568 · Received April 17, 2024

    Report

    Report Number
    3023359743-2024-00001
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Report Date
    July 9, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHYSICAL SAMPLES WERE RECEIVED HOWEVER THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO(S) PROVIDED. THIS IS THE 2ND 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. EMBECTA WAS UNABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. 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 SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    GREETINGS! MY HUSBAND AND I USED YOUR PRODUCT FOR YEARS. THIS LATEST PURCHASE OF YOUR ¿2ND GENERATION¿ IS HORRIBLE. THEY FAIL RELEASING MY MEDICATION MORE OFTEN THAN NOT, ROUGH APPLICATION TO PEN NOT SMOOTH, THEY HURT MOST EVERY USE UNLIKE THE PREVIOUS PRODUCT! VERY DISAPPOINTED IN YOUR IMPROVED VERSION. WE WANT THE OLD ONES TO RETURN. 3101692, 320550.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1892886 PEN NDL 32G 4MM PRO 100 BOX 1200 US NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320550 3101692 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown