BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILNE

    MDR report key: 23312136 · Received October 16, 2025

    Report

    Report Number
    2245270-2025-00128
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    June 19, 2025
    Report Date
    December 17, 2025
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE RECEIVED THE CATHETER WITH NEEDLE-FREE DEVICE (NON-VYGON GERMANY GMBH) AND MISSING SLIDING CLAMP AS FAULTY SAMPLE. THE CATHETER TUBE WAS SHORTENED AT THE 12 CM MARKING. THE ATTEMPT TO FLUSH THE CATHETER TUBE WITH WATER WAS SUCCESSFUL AND A LEAKAGE WAS DETECTED AT THE WING. MICROSCOPIC EXAMINATION OF THE CATHETER TUBE REVEALED A TEAR DIRECTLY AT THE WING. THE FRACTURE SURFACE WAS ROUGH, INDICATING EXCESSIVE TENSILE FORCE AND THE USE OF ALCOHOL-BASED DISINFECTION. IN GENERAL, THERE ARE VARIOUS EVENTS THAT CAN LEAD TO A LEAKING CATHETER: 1. TENSILE FORCE WHICH MAY BE CAUSED BY: DRESSING CHANGE - IN SOME INSTANCES THE CATHETER CAN BECOME ADHERED TO THE DRESSING AND ADDITIONAL PULLING IS REQUIRED TO FREE IT; PLACING STRESS ON THE LINE COULD RESULT IN A TENSILE FRACTURE. FOR BABIES, ROUTINE CARE (WHEN LIFTING THE BABY TO CHANGE THE BEDDING) AND MOVEMENT OF THE BABY ITSELF COULD RESULT IN A TENSILE FRACTURE. 2. MECHANICAL DAMAGE BY A SHARP INSTRUMENT (FOR EXAMPLE SCISSOR, FORCEPS OR SCALPEL) DURING DRESSING CHANGE. 3. ALCOHOL-BASED DISINFECTANT - CONCERNING THIS, THERE ARE SOME WARNINGS IN THE IFU: "BE AWARE THAT ORGANIC SOLVENTS SUCH AS ALCOHOL OR ACETONE MAY INTERACT WITH CATHETER MATERIAL AND WEAKEN IT." IN ADDITION, A MANUFACTURING FAULT CAN BE EXCLUDED AS EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION, AND THE CATHETER DID NOT LEAK FOR 26 DAYS AS STATED BY THE CUSTOMER ("DWELL TIME: 26 DAYS") HAVING CHECKED THE BATCH HISTORY RECORDS; NO DEVIATIONS WERE FOUND. THE BATCHES COMPLIED WITH THEIR SPECIFICATIONS AND WERE 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 ARE 30 FURTHER COMPLAINTS FOR BATCH 8235019, 15 FURTHER COMPLAINTS FOR BATCH 8220237 AND 59 FURTHER COMPLAINTS REGARDING A LEAKING CATHETER AT THE WING ON PRODUCT CODE 4G07125203 WITHIN THE LAST THREE YEARS. HOWEVER, NONE OF THESE FURTHER COMPLAINTS REGARDING A LEAKAGE IS RELATED TO A MANUFACTURING FAULT. THIS QUERY RELATES TO ALL COMPLAINTS THAT HAVE COME TO OUR ATTENTION WORLDWIDE. CORRECTIVE ACTION: AS EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION, AND THE CATHETER WORKED WELL FOR 26 DAYS BEFORE THE LEAKAGE OCCURRED, WE DO NOT BELIEVE THIS DEFECT IS MANUFACTURING RELATED. ANY MANUFACTURING PROBLEMS THAT WOULD LEAD TO A LEAK WOULD BE DETECTED BY THE USER WHEN INITIALLY FLUSHING THE CATHETER. THEREFORE, NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT AT THIS TIME.

    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

    LEAKING AT CONNECTION OF WINGS TO LINE. PICC REMOVED AND A REPLACEMENT PICC WAS PLACED.

    Description of Event or Problem · 0

    LEAKING AT CONNECTION OF WINGS TO LINE. PICC REMOVED AND A REPLACEMENT PICC WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2375214 NUTRILNE INTRAVASCULAR CATHETER LJS VYGON USA 1252.030G 24C001D

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Male