BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHLITE PEN NEEDLES

    MDR report key: 9638541 · Received January 28, 2020

    Report

    Report Number
    1832816-2020-00005
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    January 3, 2020
    Report Date
    January 3, 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
    GA, 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

    RECEIVED EMAIL FROM CUSTOMER. CONTACTED CUSTOMER FOR FOLLOW-UP AND TO GATHER MORE INFORMATION. THERE WAS NO NEEDLE AT ALL ON ONE OF THE PEN NEEDLES. SHE HAS BEEN INJECTING SINCE (B)(6) 2018 SO IS NOT NEW TO PEN NEEDLES. SHE STATES THAT OVER 30 NEEDLES BENT IN USE ON THE PATIENT SIDE OF THE NEEDLE. SHE IS INSERTING AT THE 90-DEGREE ANGLE AND THEN REMOVING STRAIGHT OUT. PART 234132. LOT Z58F2 - 2024-05-01. REPLACED DEVICES AND SENT RETURN LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102115 TECHLITE PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HTL-STREFA S.A. 234132 Z58F2 00015482234324

    Patients

    Seq Age Sex Outcome Treatment
    1