BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHLITE PEN NEEDLES

    MDR report key: 10191162 · Received June 24, 2020

    Report

    Report Number
    1832816-2020-00012
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    June 3, 2020
    Report Date
    July 6, 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 COMPLAINT PEN NEEDLES. RETAIN SAMPLES AND RETURNED SAMPLES WERE TESTED. DRAG FORCE AND PENETRATION TESTS WERE PERFORMED ON RETAIN SAMPLES AND RESULTS WERE IN SPECIFICATION RANGE. THE DEFECT WAS NOT CONFIRMED. PUNCTURE TESTS AND MICROSCOPIC ANALYSIS WAS PERFORMED ON RETURNED SAMPLES. THE DEFECT WAS NOT CONFIRMED. 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. CUSTOMER'S DAUGHTER CALLED BECAUSE HER MOM'S PEN NEEDLES KEEP BENDING. SHE STATED THAT SHE'S HAD THEM FOR ABOUT TWO MONTHS OR LONGER. CUSTOMER IS NOT INJECTING IN THE SCAR TISSUE. SHE SAID SHE'S TWISTING THE PEN NEEDLE ONTO THE SYRINGE PROPERLY. CUSTOMER STATED SHE SAID SHE PINCHES THE SKIN THEN INJECTS STRAIGHT INTO HER SKIN. VERIFIED SHE CHANGES HER NEEDLES WITH EACH INJECTION. SHE DOESN'T USE THE SAME NEEDLE TWICE. REVIEWED WITH THE CUSTOMER HOW TO PROPERLY USE THE PEN NEEDLE AND CONFIRMED SHE IS DOING EVERYTHING CORRECTLY. EVERY OTHER NEEDLE OUT OF THE BOX BENDS. REPLACED DEVICES AND SENT RETURN LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653584 TECHLITE PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HTL-STREFA S.A. 234132 A58C8 00015482234324

    Patients

    Seq Age Sex Outcome Treatment
    1