BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHLITE PEN NEEDLES

    MDR report key: 8827291 · Received July 25, 2019

    Report

    Report Number
    1832816-2019-00013
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    July 2, 2019
    Report Date
    July 2, 2019
    Manufacturer
    HTL-STREFA S.A.
    Product Code
    FMI
    UDI-DI
    00015482234324
    PMA / PMN Number
    K143437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVOLVED IN THE INCIDENT WAS RETURNED TO ARKRAY USA AND FORWARDED TO THE MANUFACTURER FOR EVALUATION. DHRS WERE REVIEWED AND NO RECORDS CONFIRMING THE DEFECT WERE OBSERVED. ARCHIVAL SAMPLES MEET REQUIREMENTS OF SPECIFICATION. ADDITIONALLY, 10 RANDOMLY SELECTED PEN NEEDLES FROM ARCHIVAL SAMPLES WERE ASSEMBLED ON PEN INJECTOR. WITH EVERY ATTEMPT, DROPLETS ON THE CANNULA WERE OBSERVED AND INJECTION OF APPLIED DOSAGE CAN BE SEEN WHICH 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. RETURNED SAMPLES MEET REQUIREMENTS OF SPECIFICATION. ADDITIONALLY, RETURNED PEN NEEDLES WERE ASSEMBLED ON PEN INJECTOR. WITH EVERY ATTEMPT, DROPLETS ON THE CANNULA WERE OBSERVED AND INJECTION OF APPLIED DOSAGE CAN BE SEEN WHICH 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. THE DEFECT IS NOT CONFIRMED. ROOT CAUSE ANALYSIS WAS NOT CONDUCTED. NO CAPA INITIATED. NO FURTHER ACTION. COMPLAINT CLOSED.

    Description of Event or Problem · 1

    CUSTOMER IS USING TECHLITE PEN NEEDLES. LOT Y58J3 - 32 GUAGE X 4 MM - 100CT. PART 234132. HE IS USING A "BASAGLAR" PEN THAT HE STATES IS MADE BY LILY KWIKPEN. HE STATES THE INJECTION IS NOT "SMOOTH" AND INSULIN LEAKS FROM THE SIDE. HE DOES NOT BELIEVE THAT THE TECHLITE PEN NEEDLES ARE COMPATIBLE WITH THIS PEN, BUT OUR ADVERTISING STATES IT SHOULD BE. INFORMED CUSTOMER WE CAN REPLACE HIS PEN NEEDLES AND CAN TRY THEM WITH HIS KWIK PEN. INFORMED PRODUCT WILL ARRIVE IN 3 TO 5 BUSINESS DAYS. GAVE INSTRUCTIONS TO SEND PRODUCT BACK WITH RETURN LABEL. PLEASE REPLACE PEN NEEDLES AND SEND RL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619864 TECHLITE PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HTL-STREFA S.A. 234132 Y58J3 00015482234324

    Patients

    Seq Age Sex Outcome Treatment
    1