BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXEL 10-12ML SYR ONLY L-L

    MDR report key: 19366736 · Received May 21, 2024

    Report

    Report Number
    1035907-2024-00022
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    April 23, 2024
    Report Date
    May 21, 2024
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    UDI-DI
    00020221262650
    PMA / PMN Number
    K861153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER OUR INVESTIGATION: 100 RETAINED SAMPLES VISUALLY INSPECTED FOR PACKAGING AND PRODUCT DAMAGE - PACKAGING INTACT AND NO PRODUCT DAMAGE FOUND 13 RANDOM SAMPLES UNDERWENT A SIMULATED SUCTION TEST - NO LEAKAGE FOUND AT LUER INTERFACE AND RUBBER STOPPER 13 DIFFERENT RANDOM SAMPLES TESTED MET THE LEAK REQUIREMENTS OF ISO7886-1:2017 ANNEX B AND ANNEX D 13 DIFFERENT RANDOM SAMPLES TESTED MET THE LEAK REQUIREMENTS OF ISO80369-7:2021 6.1.2 AND 6.1.3 FACTORY PRODUCTION RECORDS WERE REVIEWED WITH NO NOTED ISSUES BASED ON THE REVIEW OF PRODUCTION RECORDS AND TESTING OF RETAINED SAMPLES - THE PRODUCTS ARE QUALIFIED AND MEET THE APPLICABLE STANDARDS. AFFECTED PRODUCT WAS NOT RETAINED AND IS NOT AVAILABLE FOR EVALUATION. THEREFORE, ROOT CAUSE IS UNKNOWN. THE CUSTOMER STATED THAT MORE DETAILED VIDEOS WOULD BE SENT TO EXEL BUT HAVE NOT SENT ANY TO THIS DATE. THERE ARE NO OTHER SIMILAR COMPLAINTS IN THIS LOT. (B)(4).

    Description of Event or Problem · 0

    NOTHING HAS A GOOD SEAL WHEN YOU SCREW IT ONTO THE SYRINGE, ESPECIALLY BLUNT NEEDLES OR 18 GAUGE SYRINGES. THE PLUNGER COMES OUT TOO EASY. IT TWIST TOO EASY AND IT CAUSES LEAKAGE AS WELL AS THE PLUNGER, BECOMING DETACHED FROM THE PULL PART ITSELF. IT'S ON ALL THE SYRINGES. IT'S NOT JUST THAT ONE. IT'S ON EVERYONE YOU PULL. BLOOD GETS EVERYWHERE, ALL OVER OTHER TUBES WHICH MAKES US HAVE TO THROW THOSE AWAY. BLOOD GETS ON THE COUNTERS AND FLOOR. THE AMOUNT OF BLOOD IT SPRAYS AND THE NUMBER OF TUBES I MUST THROW AWAY DUE TO CONTAMINATION OF THE RUBBER CENTER GETTING COVERED IS CRAZY. I HAVE HAD IT PERSONALLY SPRAY TO THE POINT IT GOT ON MY FACE AND NECK IT LEAKS BEHIND THE PLUNGER, LIKE THE SEAL ISN'T THERE. THERE'S ALSO NOT ENOUGH PRESSURE WITH THEM, HENCE THE LEAKAGE BEHIND THEM. IS NOT JUST A LEAK. IT SPRAYS. WE SENT ALL OF THEM BACK. THERE'S NOT JUST A FEW THAT DID IT, ALL OF THEM DID IT. I COULD GRAB AT RANDOM AND IT HAPPENED. BUT YES 2 DIFFERENT ISSUES WITH THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584238 EXEL 10-12ML SYR ONLY L-L SYRINGE ONLY FMF EXELINT INTERNATIONAL, CO. 211105 00020221262650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown