BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICATH

    MDR report key: 23427480 · Received October 30, 2025

    Report

    Report Number
    2245270-2025-00142
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 23, 2025
    Report Date
    December 22, 2025
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K954302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE RECEIVED THE SEALING PAPER, CATHETER AND 10 ML SYRINGE MADE BY BD AS FAULTY SAMPLE.THE ATTEMPT TO FLUSH THE CATHETER WITH WATER WAS SUCCESSFUL. EVEN AFTER CLAMPING THE CATHETER TIP TO INCREASE THE PRESSURE, NO LEAKAGE WAS DETECTED. MICROSCOPIC EXAMINATION OF THE CATHETER TUBE AND JUNCTION BETWEEN THE CATHETER TUBE AND EXTENSION LINE REVEALED NO DAMAGE.. THEREFORE, WE DO NOT COMPREHEND THE REASON OF COMPLAINT. HAVING CHECKED THE BATCH HISTORY RECORDS; NO DEVIATIONS WERE FOUND. THE BATCH COMPLIED WITH ITS SPECIFICATION AND WAS RELEASED.EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION. THE TENSILE FORCE AND DIMENSIONS OF CATHETER AND SET COMPONENTS ARE RANDOMLY CHECKED. INCOMING GOODS INSPECTIONS AND TWO 100% VISUAL TESTS AFTER PACKAGING ARE CARRIED OUT. THERE IS ONE FURTHER COMPLAINTS FOR BATCH 8220239, BUT NO FURTHER COMPLAINT REGARDING A LEAKING CATHETER IMMEDIATELY AFTER PLACEMENT ON PRODUCT CODE 4G07126120 WITHIN THE LAST THREE YEARS. THIS QUERY RELATES TO ALL COMPLAINTS THAT HAVE COME TO OUR ATTENTION WORLDWIDE. NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT AS THERE IS NO HINT OF A MANUFACTURING FAULT.

    Additional Manufacturer Narrative · 0

    THE MALFUNCTIONING DEVICE WILL BE RETURNED FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. UPON RECEIPT, IT WILL BE INVESTIGATED. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE REPORTED TO THE FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA A FOLLOW-UP MDR.

    Description of Event or Problem · 0

    LINE WAS ALREADY INSERTED AND IT WAS NOTED THAT LINE WAS LEAKING WHEN FLUSHED. I PULLED THE LINE OUT.

    Description of Event or Problem · 0

    LINE WAS ALREADY INSERTED AND IT WAS NOTED THAT LINE WAS LEAKING WHEN FLUSHED. I PULLED THE LINE OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541551 PREMICATH INTRAVASCULAR CATHETER LJS VYGON USA 1261.20G 24G019D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown