BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHLITE PEN NEEDLES

    MDR report key: 8667623 · Received June 4, 2019

    Report

    Report Number
    1832816-2019-00010
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 10, 2019
    Report Date
    June 11, 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. ON BOTH ARCHIVAL AND RETURNED SAMPLES, DRAG FORCE AND PENETRATION FORCE WERE MEASURED. SAMPLES MEET REQUIREMENTS OF SPECIFICATION. ON BOTH ARCHIVAL SAMPLES (10) AND RETURNED SAMPLES (6), PEN NEEDLES FROM EACH SAMPLE WERE PUNCTURE TESTED INTO A SILICONE RUBBER CUBE WITH A HARDNESS OF 55 SHORE IMITATING HUMAN TISSUE. NO DEFECTS OBSERVED. ON BOTH ARCHIVAL SAMPLES (10) AND RETURNED SAMPLES (6), PEN NEEDLES WERE ASSEMBLED ONTO PEN INJECTOR. WITH EVERY ASSEMBLY ATTEMPT, DROPLETS ON THE CANNULA WERE OBSERVED AND INJECT OF THE APPLIED DOES CAN BE SEEN WHICH CONFIRMS THE CORRECTNESS OF THE PEN NEEDLE ASSEMBLY AND THE PATENCY OF THE NEEDLES. FLUID FLOW WAS OBTAINED IN ALL PEN NEEDLES. NO DEFECTS OBSERVED. NO CORRECTIVE ACTION. COMPLAINT CLOSED.

    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

    CALLER IS CALLING TO COMPLAIN THAT THE NEEDLES ARE BENDING IN THE PROCESS OF DOING THE INJECTION AND HE MUST PUSH THE PLUNGER VERY HARD TO GET HIS FULL DOSE OF INSULIN. HE IS USING THE LILLY HUMALOG PEN. CUSTOMER ONLY USES THE NEEDLES ONCE. SIZE IS 100CT 0.23 X 4MM 32G. HE SAID THAT IT HAS HAPPENED WITH MULTIPLE BOXES OF NEEDLES. PART 234132. LOT Y58ZC9 - 2023-10-01. REPLACED DEVICES AND SENT RL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459495 TECHLITE PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HTL-STREFA S.A. 234132 Y58ZC9 00015482234324

    Patients

    Seq Age Sex Outcome Treatment
    1