BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 23913558 · Received December 29, 2025

    Report

    Report Number
    2245270-2025-00158
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    September 16, 2025
    Report Date
    March 3, 2026
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF THE SAMPLE AN INVESTIGATION WILL BE COMPLETED, THE RESULTS WILL BE SENT TO YOU THROUGH A FOLLOW UP MDR.

    Additional Manufacturer Narrative · 0

    WE RECEIVED ONE CATHETER AS A FAULTY SAMPLE. THE SLIDING CLAMP WAS MISSING, AND AN ADDITIONAL EXTENSION LINE (NOT A VYGON GERMANY GMBH PRODUCT) WAS ATTACHED TO THE CATHETER. FURTHERMORE, THE CATHETER TUBE WAS SHORTENED DISTAL TO 15 CM, WITH ORGANIC RESIDUES ADHERED BETWEEN THE 27 CM AND 28 CM MARKINGS. FLUSHING THE CATHETER WITH WATER WAS SUCCESSFUL, AND A LEAKAGE NEAR THE WING WAS DETECTED. MICROSCOPIC EXAMINATION REVEALED A 2.1 MM TEAR DISTAL TO THE WING. THE TEAR WAS ROUGH AND UNEVEN, INDICATING MECHANICAL DAMAGE AND OVERSTRESSING. 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. 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. A REVIEW OF THE COMPONENT BATCH HISTORY RECORDS WAS PERFORMED, AND NO DEVIATIONS WERE FOUND. THE BATCHES COMPLIED WITH THEIR SPECIFICATIONS AND WERE RELEASED. EACH CATHETER UNDERGOES FLOW AND LEAK TESTING DURING PRODUCTION AS PART OF THE QUALITY CONTROL PROCESS. 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. A REVIEW OF VYGON USA'S COMPLAINT DATA IDENTIFIED THREE REPORTED CATHETER ISSUES INVOLVING LEAKAGE OR CRACKING FOR LOT 24E007D, ALL ORIGINATING FROM THIS FACILITY. CORRECTIVE ACTION: BASED ON THE INVESTIGATION, THIS ISSUE IS ATTRIBUTED TO MECHANICAL DAMAGE AND OVERSTRESSING, WITH NO INDICATIONS OF A MANUFACTURING-RELATED DEFECT. THEREFORE, VYGON GERMANY'S QUALITY MANAGEMENT HAS NOT INITIATED ANY FURTHER CORRECTIVE ACTION AT THIS TIME.

    Description of Event or Problem · 0

    FRACTURED PICC.

    Description of Event or Problem · 0

    FRACTURED PICC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408117 NUTRILINE INTRAVASCULAR CATHETER LJS VYGON USA 1252.35G 24E007D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown