BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 23290381 · Received October 15, 2025

    Report

    Report Number
    2245270-2025-00123
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    June 9, 2025
    Report Date
    December 15, 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

    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.

    Additional Manufacturer Narrative · 0

    WE RECEIVED THE CATHETER WITH NEEDLE-FREE DEVICE (NON-VYGON GERMANY GMBH) AS FAULTY SAMPLE. DRIED SOLUTION RESIDUES WERE VISIBLE INSIDE EXTENSION LINE AND THE CATHETER TUBE WAS SHORTENED DISTAL TO THE 16 CM MARKING. THE ATTEMPT TO FLUSH THE CATHETER TUBE WITH WATER WAS NOT SUCCESSFUL, PROBABLY DUE TO THE DRIED RESIDUES. MICROSCOPIC EXAMINATION OF THE CATHETER TUBE REVEALED A TEAR DIRECTLY AT THE WING. THE FRACTURE SURFACE WAS ROUGH, INDICATING EXCESSIVE TENSILE FORCE. 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 22 DAYS AS STATED BY THE CUSTOMER ("DWELL TIME:22 DAYS"). 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 ARE THREE FURTHER COMPLAINTS FOR BATCH 8236275 AND FIVE FURTHER COMPLAINTS REGARDING A LEAKING CATHETER AT THE WING ON PRODUCT CODE 4G07125231 WITHIN THE LAST THREE YEARS. HOWEVER, NONE OF THESE FURTHER COMPLAINTS IS RELATED TO A MANUFACTURING FAULT. 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.

    Description of Event or Problem · 0

    LEAKING, CRACKED NEAR WINGS.

    Description of Event or Problem · 0

    LEAKING, CRACKED NEAR WINGS. PICC REMOVED AND A REPLACEMENT PICC WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5209 NUTRILINE INTRAVASCULAR CATHETR, LONG-TERM LJS VYGON USA 1252.31G 24F005D

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male