BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHLITE PEN NEEDLES

    MDR report key: 8443620 · Received March 22, 2019

    Report

    Report Number
    1832816-2019-00006
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Date of Event
    March 6, 2019
    Report Date
    May 23, 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 · 0

    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. NO CORRECTIVE ACTION. COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    PRODUCT INVOLVED IN INCIDENT WAS NOT RETURNED FOR EVALUATION. IF PRODUCT IS RETURNED, ARKRAY WILL SEND TO MANUFACTURER FOR TESTING AND FILE A FOLLOW-UP REPORT WHEN EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    CALLER SAID THAT THE INSULIN DOES NOT ALWAYS COME THROUGH THE NEEDLE AND SHE SOMETIMES NEEDS TO USE UP TO THREE NEEDLES FOR AN INJECTION. SHE ONLY USES THE NEEDLES ONCE AND HAS NOT NOTICED THE NEEDLE BEING BENT ON EITHER END. SHE IS USING LANTUS AND VICTOZA. PART 234132. LOT Y58J3, EXPIRATION 2023-02-01. REPLACED PEN NEEDLES AND SENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238663 TECHLITE PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUME FMI HTL-STREFA S.A. 234132 Y58J3 00015482234324

    Patients

    Seq Age Sex Outcome Treatment
    1