BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXEL IV CATH 24GX3/4"

    MDR report key: 25247856 · Received May 21, 2026

    Report

    Report Number
    1035907-2026-00054
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Report Date
    May 21, 2026
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FOZ
    UDI-DI
    00020221267518
    PMA / PMN Number
    K895768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS CONDUCTED ON PRODUCT # 26751, LOT # 240902, WHICH INCLUDED THE FOLLOWING: INCOMING INSPECTION AN INCOMING INSPECTION HAS BEEN PERFORMED IN ACCORDANCE WITH SOP-11 INCOMING INSPECTION PROCEDURE ON PRODUCT # 26751, LOT #240902. THE BATCH MET THE ESTABLISHED CRITERIA FOR PRODUCT RELEASE, AND NO NONCONFORMITIES WERE IDENTIFIED. PRODUCTION PROCESS REVIEW THE BATCH RECORDS OF THE PRODUCTION PROCESS AND THE FINISHED PRODUCT INSPECTION REPORTS WERE REVIEWED. NO CHANGES TO RAW MATERIALS, PRODUCTION PROCESSES, OR INSPECTION METHODS WERE IDENTIFIED. ALL REVIEWED DOCUMENTATIONS COMPLIED WITH PRODUCT RELEASE STANDARDS REQUIREMENTS, AND THE FINISHED PRODUCTS MET ALL SPECIFIED ACCEPTANCE CRITERIA. NO ABNORMALITIES OR NON-CONFORMITIES WERE FOUND. RETAINED SAMPLES INSPECTION FIFTY RETAINED SAMPLES OF INDWELLING CATHETERS FROM PRODUCT # 26751, LOT #240902 WERE SUBJECTED TO VISUAL INSPECTION. ALL SAMPLES WERE FOUND TO BE CLEAN AND FREE OF FOREIGN MATTER. ADDITIONALLY, FIVE SAMPLES FROM THE RETAINED SAMPLES UNDERWENT VISUAL INSPECTION OF THE NEEDLE CANNULA AND SURFACES. NO VISIBLE ACCUMULATION OF LUBRICANT OR LIQUID DROPLETS WAS OBSERVED. CAUSE ANALYSIS BASED ON THE CUSTOMER'S DESCRIPTION, IT IS LIKELY THAT THE "LIQUID/WATER" IS THE ACCUMULATION OF SILICON OIL LUBRICANT OVER TIME, WHICH MAY APPEAR AS LIQUID OR WATER-LIKE DROPLETS. SUCH ACCUMULATION IS DIFFICULT TO DETECT DURING THE PRODUCTION PROCESS BECAUSE THE MATERIAL MAY REQUIRE TIME BEFORE BECOMING VISIBLE. THE LUBRICANT USED IN THE PRODUCT IS DIMETHYL SILICON OIL, WHICH HAS BEEN PREVIOUSLY EVALUATED THROUGH BIOLOGICAL EVALUATION AND HAS BEEN DETERMINED TO BE SUITABLE FOR INTENDED CLINICAL USE. HOWEVER, THE CUSTOMER DID NOT RETURN THE SAMPLES FOR EVALUATION, THEREFORE, CONFORMITY TESTING COULD NOT BE PERFORMED. BASED ON THE AVAILABLE DATA, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. POTENTIAL EXPLANATION COULD BE A LOCALIZED ACCUMULATION OF SILICON OIL, HOWEVER, THIS REMAINS UNCONFIRMED. THIS COMPLAINT WILL BE CLOSED IN OUR SYSTEM. NO SIMILAR COMPLAINTS WITHIN THE LOT. (B)(4)

    Description of Event or Problem · 0

    CUSTOMER REPORTED USING 24G CATHETERS AND WHEN THEY OPENED THE CAP FROM THE SEAL THERE WAS VISIBLE WATER/LIQUID. THE LIQUID WAS OBSERVED BEFORE USE ON A PATIENT AND NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241019 EXEL IV CATH 24GX3/4" IV CATHETER FOZ EXELINT INTERNATIONAL, CO. 240902 00020221267518

    Patients

    Seq Age Sex Outcome Treatment
    1