BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHLITE PEN NEEDLES

    MDR report key: 16787930 · Received April 21, 2023

    Report

    Report Number
    1832816-2023-00006
    Event Type
    Malfunction
    Date Received
    April 21, 2023
    Report Date
    March 27, 2023
    Manufacturer
    HTL-STREFA S.A.
    Product Code
    FMI
    UDI-DI
    00015482234324
    PMA / PMN Number
    K143437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER HAD NO COMPLAINT DEVICES LEFT TO RETURN. ARCHIVAL SAMPLES WERE EVALUATED. DHRS WERE REVIEWED AND NO RECORDS CONFIRMING THE DEFECTS WERE OBSERVED. PATENCY OF CANNULA WAS VERIFIED BY VISUAL ASSESSMENT IN MAGNIFICATION ON MICROSCOPE. LIGHT COMING THROUGH THE CANNULA WAS VISIBLE. 10 RANDOMLY SELECTED PEN NEEDLES FROM THE ARCHIVAL SAMPLE WERE ASSEMBLED ON THE PEN INJECTOR. WITH EVERY ASSEMBLY ATTEMPT, DROPLETS ON THE CANNULA WERE OBSERVED AND INJECTION OF THE APPLIED DOSE CAN BE SEEN, WHICH IS VISIBLE ON THE PAPER AND CONFIRMS THE CORRECTNESS OF THE PEN NEEDLE ASSEMBLY ON THE PEN AND THE PATENCY OF THE NEEDLES. FLUID FLOW WAS OBTAINED IN ALL TESTED PEN NEEDLES. COMPLAINT NOT CONFIRMED. RCA NOT CONDUCTED. NO CAPA. COMPLAINT CLOSED.

    Description of Event or Problem · 0

    PART 234132, LOT C58K9, 2027-07-01 - 100CT. THE CALLER STATES THAT THE NEEDLES ARE BLOCKED, AND NO LIQUID IS COMING OUT, AND HE SOMETIMES NEEDS TO USE UP TO THREE NEEDLES TO DO AN INJECTION. CALLER USES NEEDLES RIGHT AWAY WITHOUT PRIMING AND DOESN'T PRIME NEEDLES BECAUSE INSULIN IS EXPENSIVE. THE CALLER DOES NOT HAVE ANY UNUSED NEEDLES LEFT TO RETURN. HE DOES HAVE ONES THAT DID NOT WORK, BUT ARE USED, BUT I ADVISED HIM NOT TO RETURN THOSE. REPLACED DEVICES FOR CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865173 TECHLITE PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HTL-STREFA S.A. 234132 C58K9 00015482234324

    Patients

    Seq Age Sex Outcome Treatment
    1 Male