BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHLITE PEN NEEDLES

    MDR report key: 9187316 · Received October 14, 2019

    Report

    Report Number
    1832816-2019-00024
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    September 17, 2019
    Report Date
    November 26, 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

    CUSTOMER RETURNED 85 PEN NEEDLES. DRAG FORCE AND PENETRATION FORCE WERE MEASURED AND RESULTS WERE WITH THE SPECIFICATION RANGE. 10 RETURNED PEN NEEDLES WERE TESTED WITH TRIPLE PUNCTURE TEST INTO A SILICONE CUBE WITH A HARDNESS OF 55 SHORE, IMITATING HUMAN SKIN HARDNESS. ADDITIONALLY, 10 RANDOMLY SELECTED PEN NEEDLES FROM 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. 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 THE INCIDENT WAS RETURNED TO ARKRAY USA AND FORWARDED TO THE MANUFACTURER FOR EVALUATION. WE HAVE NOT YET RECEIVED EVALUATION RESULTS. ARKRAY WILL FILE A FOLLOW-UP REPORT WHEN DEVICE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE REPLACEMENT DEVICES FROM HIS ORIGINAL COMPLAINT CALL ON (B)(6) 2019 ARE NOT WORKING ANY BETTER THAN THE COMPLAINT DEVICES HE ORIGINALLY REPORTED ON (B)(6) 2019. TODAY HE STATED THAT HE HAS HAD TO USE FIVE OR SIX DIFFERENT PEN NEEDLES TO PROPERLY INJECT HIS INSULIN. HE CLAIMED THAT THE NEEDLES FEEL DULL OR BLUNT WHEN INSERTING INTO THE SKIN AND ARE VERY PAINFUL AND THAT THE FLOW OF INSULIN IS NOT GOOD, AND HE HAD ONE GET "CLOGGED" TODAY WHEN ATTEMPTING TO INJECT THE INSULIN. CUSTOMER STATED HE ONLY USES THE PEN NEEDLES ONCE AND IS NOT ATTEMPTING TO REUSE THEM. HE STATED HE DOES NOT HAVE ISSUES PUTTING THE PEN NEEDLE ON THE PEN. LOT Z58F3, EXPIRATION 2024-05-01. PART 234132. REPLACED PRODUCT AND SENT RETURN LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981891 TECHLITE PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HTL-STREFA S.A. 234132 Z58F3 00015482234324

    Patients

    Seq Age Sex Outcome Treatment
    1