BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXEL IV CATH 22GX1"

    MDR report key: 23428707 · Received October 30, 2025

    Report

    Report Number
    1035907-2025-00038
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Report Date
    October 28, 2025
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FOZ
    UDI-DI
    00020221267464
    PMA / PMN Number
    K895768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). AN INCOMING INSPECTION WAS PERFORMED ON PRODUCT # 26746, LOT #240401 FOLLOWING SOP-11 INCOMING INSPECTION PROCEDURE. THIS LOT MET THE THE INSPECTION CRITERIA FOR PRODUCT RELEASE, WITH NO ABNORMALITIES NOTED. THE CMO CONDUCTED AN INVESTIGATION THAT INCLUDED THE FOLLOWING:PRODUCTION PROCESS REVIEW: THE BATCH PRODUCTION REVIEW AND FINISHED PRODUCT RELEASE INSPECTION REPORT FOR THIS BATCH WERE REVIEWED. THERE WERE NO CHANGES IN RAW MATERIALS OR PRODUCTION PROCESS, AND THE FINISHED PRODUCT PASSED THE RELEASE INSPECTION. NO NON CONFORMITIES WERE OBSERVED. RETAINED SAMPLE TESTING:APPEARANCE INSPECTION: TEN (10) RETAINED SAMPLES FROM THIS LOT WERE TESTED FOR VISUAL OR APPEARANCE INSPECTION. ALL TESTED SAMPLES COMPLIED WITH THE REQUIREMENTS, AND ALL COMPONENTS OF THE PRODUCT WERE PROPERLY ASSEMBLED WITHOUT AY DETACHMENT OR DAMAGE OBSERVED. SEAL INTEGRITY TESTING: FIVE (5) SAMPLES WERE SELECTED FOR SEAL INTEGRITY TESTING. ALL TESTED SAMPLES COMPLIED WITH THE TEST CRITERIA, WITH NO AIR LEAKAGE NOTED. SIMULATED CLINICAL TESTING: FIVE (5) SAMPLES WERE SELECTED FOR SIMULATED CLINICAL TESTING. ALL TESTED SAMPLES MET THE REQUIREMENTS FOR SIMULATION TESTS, AND NO LIQUID LEAKAGE WAS FOUND. CAUSE ANALYSIS BASED ON THE PHOTOS SUBMITTED, THE FOLLOWING POSSIBLE SCENARIO MAY HAVE OCCURRED. THE NEEDLE HUB MAY HAVE BEEN ACCIDENTALLY PULLED OUT DURING CLINICAL USE, CREATING A GAP BETWEEN THE CATHETER AND THE NEEDLE. THIS COULD HAVE ALLOWED BLOOD TO FLOW FROM THE PERIPHERAL CATHETER INTO THE CATHETER HUB, RESULTING IN BLOOD LEAKAGE. THE PERIPHERAL HUB ASSEMBLY MAY HAVE BEEN DAMAGED WHICH COULD ALSO LEAD TO A BLOOD LEAKAGE. HOWEVER, THESE CAUSES COULD NOT BE CONFIRMED DUE TO THE ABSENCE OF THE DEFECTIVE DEVICE TO EXAMINE. BASED ON AVAILABLE INFORMATION, WE WERE UNABLE TO DETERMINE THE ROOT CAUSE, AND/OR UNABLE TO REPLICATE THE ISSUE IN OUR INVESTIGATION. THEREFORE, THE ROOT CAUSE REMAINS UNCONFIRMED. THIS COMPLAINT CAN NOW BE CLOSED. NO SIMILAR COMPLAINTS FOUND IN THE LOT.

    Description of Event or Problem · 0

    THE PLASTIC PART OF THE CATHETER (IN THE VEIN) WAS NOT PROPERLY CONNECTED TO THE EXTERNAL PLASTIC AND THE PATIENT (SEDATED FOR COHAT OR VETERINARY PET) BLED FROM THAT JUNCTION. OUR MAJOR CONCERN WAS THAT THE INTERNAL PORTION COULD HAVE BROKEN OFF AND CAUSED SERIOUS HARM OR DEATH TO THE PATIENT. WE NOTICED THE BLEEDING AROUND IT AND REMOVED THE CATHETER PROMPTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342976 EXEL IV CATH 22GX1" Catheter, intravascular, therapeutic, short-term less than 30 days FOZ EXELINT INTERNATIONAL, CO. 240401 00020221267464

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown