BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHLITE PEN NEEDLES

    MDR report key: 10305287 · Received July 21, 2020

    Report

    Report Number
    1832816-2020-00014
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 22, 2020
    Manufacturer
    HTL-STREFA S.A.
    Product Code
    FMI
    UDI-DI
    00015482234324
    PMA / PMN Number
    K143437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED 14 PEN NEEDLES. ON 10 RETAIN AND ALL RETURNED PEN NEEDLES, THE NEEDLE PATENCY WAS CHECKED UNDER A MICROSCOPE BY OBSERVING LIGHT PASSING THROUGH THE LUMEN OF THE CANNULA. 10 RETAINS AND ALL RETURNED PEN NEEDLES WERE THEN ASSEMBLED ON THE PEN INJECTOR. WITH EVERY ASSEMBLY ATTEMPT, DROPLETS ON THE CANNULA WERE OBSERVED AND INJECTION OF THE 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. NO DEFECTS UNDER COMPLAINT WERE OBSERVED. ROOT CAUSE ANALYSIS WAS NOT CONDUCTED. NO CAPA INITIATED.

    Additional Manufacturer Narrative · 1

    PRODUCT INVOLVED IN INCIDENT WAS RETURNED FOR EVALUATION AND FORWARDED TO THE MANUFACTURER FOR FURTHER EVALUATION. EVALUATION RESULTS ARE PENDING. ARKRAY WILL FILE A FOLLOW-UP REPORT WHEN EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    PART 234132. CALLER HAS HAD FOUR NEEDLES IN HER CURRENT BOX THAT WILL NOT PRIME AND LET THE INSULIN THROUGH. REPLACED DEVICES AND SENT RL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766764 TECHLITE PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HTL-STREFA S.A. 234132 A58A4 00015482234324

    Patients

    Seq Age Sex Outcome Treatment
    1