BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHLITE PEN NEEDLES

    MDR report key: 8518617 · Received April 16, 2019

    Report

    Report Number
    1832816-2019-00009
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 19, 2019
    Report Date
    March 19, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHRS WERE REVIEWED AND NO RECORDS CONFIRMING THE DEFECT WERE OBSERVED. ARCHIVAL AND RETURNED SAMPLES MEET REQUIREMENTS OF SPECIFICATION. ADDITIONALLY, 10 RANDOMLY SELECTED PEN NEEDLES FROM ARCHIVAL AND RETURNED 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. 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

    CALLER IS USING PEN NEEDLES WITH VICTOZA. SOMETIMES HE PUTS ONE ON AND THE INSULIN WILL NOT COME OUT. THE NEEDLE IS NOT BENT AT ALL AND HE ONLY USES THEM ONCE. PART 234132. REPLACED PEN NEEDLES AND SENT RL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311474 TECHLITE PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HTL-STREFA S.A. 234132 X56ZH2 00015482234324

    Patients

    Seq Age Sex Outcome Treatment
    1