BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHLITE PEN NEEDLES

    MDR report key: 10066501 · Received May 18, 2020

    Report

    Report Number
    1832816-2020-00011
    Event Type
    Malfunction
    Date Received
    May 18, 2020
    Date of Event
    April 20, 2020
    Report Date
    May 4, 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

    CUSTOMER JUST STARTED USING OUR PRODUCTS AND HE IS HAVING ISSUES WITH GETTING THE NEEDLE INTO HIS SKIN AND SOMETIMES BENDING. HE HAS THREE BOXES AND HAS ONLY USED ABOUT 8 OF THEM SO FAR AND HAS BEEN AN ISSUE WITH EACH NEEDLE. CALLER DOESN'T USE SAME INJECTION SITE. CALLER HAS NO SCAR TISSUE AND NOT INJECTING INTO NAVEL. NEVER REUSES NEEDLES. PART 234132. REPLACING TWO BOXES AND SENDING LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529426 TECHLITE PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HTL-STREFA S.A. 234132 Z58W6 00015482234324

    Patients

    Seq Age Sex Outcome Treatment
    1