BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHLITE PEN NEEDLES

    MDR report key: 8443608 · Received March 22, 2019

    Report

    Report Number
    1832816-2019-00005
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Date of Event
    February 28, 2019
    Report Date
    February 28, 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 · 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

    CUSTOMER IS USING TECHLITE PEN NEEDLES. SHE IS USING PART 234132. LANTUS AND HUMALOG QUICK PEN. SHE STATED THAT THE TECHLITE PEN NEEDLES WEREN'T RELEASING ANY INSULIN. WALKED CUSTOMER THROUGH STEPS TO TROUBLESHOOT THE PEN NEEDLE. I ASKED CALLER TO REMOVE THE PAPER AND TWIST THE PEN NEEDLE ONTO HER INSULIN PEN. ASKED CALLER TO ADJUST INSULIN TO ABOUT 2CC TO TEST IF INSULIN WILL BE RELEASED. SHE PRESSED THE BUTTON AND INSULIN WAS RELEASED. EXPLAINED THAT IT APPEARS THAT HER PEN NEEDLES ARE WORKING. SHE STATED THAT FIVE TIMES A WEEK IT DOESN'T WORK TO RELEASE INSULIN. EXPLAINED THAT I WILL REPLACE HER PEN NEEDLES AND SEND A NEW BOX WITH A PRE-PAID RETURN LABEL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238600 TECHLITE PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HTL-STREFA S.A. 234132 W46ZA5 00015482234324

    Patients

    Seq Age Sex Outcome Treatment
    1