BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHLITE PEN NEEDLES

    MDR report key: 11790231 · Received May 7, 2021

    Report

    Report Number
    1832816-2021-00011
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 24, 2021
    Manufacturer
    HTL-STREFA S.A.
    Product Code
    FMI
    UDI-DI
    00015482234324
    PMA / PMN Number
    K143437
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION COMPLETED. DHR'S WERE REVIEWED AND NO RECORDS CONFIRMING THE DEFECT WERE OBSERVED. 10 PEN NEEDLES FROM ARCHIVAL SAMPLE AND ALL RETURNED SAMPLES WERE ASSEMBLED ONTO PEN INJECTOR AND WERE TRIPLE PUNCTURED WITH PROPER TECHNIQUE INTO SILICONE CUBE WITH A HARDNESS IMITATING HUMAN SKIN. NO DEFECTS WERE OBSERVED DURING TESTING. 10 PEN NEEDLES FROM ARCHIVAL SAMPLE AND ALL RETURNED SAMPLES WERE ASSEMBLED ONTO PEN INJECTOR AND TESTED FOR FLUID FLOW. DROPLETS ON THE CANNULA WERE OBSERVED AND INJECTION OF THE APPLIED DOSE COULD BE OBSERVED. NO DEFECTS OBSERVED DURING TESTING.

    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

    CALLER SAID THESE WERE 32G X 4MM NEEDLES IN A 100CT BOX THAT WAS WHITE IN COLOR. CALLER WAS UNABLE TO FIND LOT OR BATCH NUMBER BUT FOUND PRODUCT NUMBER OF 234132. CALLER SAYS THE NEEDLES THEY USE BEND AFTER BEING INSERTED IN THEIR SKIN. CALLER ALSO SAYS THEY DO NOT GET THE FULL AMOUNT OF INSULIN AND NEED TO USE A SECOND NEEDLE. I MADE SURE CALLER APPLIED CAP CORRECTLY BY PLACING STRAIGHT ON. CALLER INJECTS AT 90-DEGREE ANGLE. CALLER SAID THEY DID NOT INJECT INTO SCAR TISSUE. I TOLD CALLER WE CAN REPLACE THE NEEDLES AND EXPLAINED THE RETURN PROCESS AS WE WOULD LIKE IT BACK FOR SOME TESTING. REPLACED DEVICES AND SENT RL. CONTACTED CUSTOMER AFTER INITIAL CALL AND WAS ABLE TO GATHER THE LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685319 TECHLITE PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HTL-STREFA S.A. 234132 A58T8 00015482234324

    Patients

    Seq Age Sex Outcome Treatment
    1