BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 23426937 · Received October 30, 2025

    Report

    Report Number
    2245270-2025-00136
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    July 10, 2025
    Report Date
    December 22, 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 A NEEDLE-FREE CONNECTOR AND A 10 ML SYRINGE AS WELL AS A CLAMP SCISSORS AS FAULTY SAMPLE.THE CATHETER WAS SNAPPED BETWEEN THE 26 CM AND 27 CM MARKING.MICROSCOPIC EXAMINATION REVEALED THAT BOTH FRACTURE SURFACES WERE SMOOTH/EVEN AND SHOWED GROOVES, INDICATING A CUT/MECHANICAL DAMAGE BY A SHARP INSTRUMENT (FOR EXAMPLE SCISSOR OR SCALPEL). IN ADDITION, A MANUFACTURING FAULT CAN BE EXCLUDED AS EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION, AND THE CATHETER DID NOT SNAP FOR 3 WEEKS AS STATED BY THE CUSTOMER ("DWELL TIME WAS 3 WEEKS"). 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. TWO DIFFERENT BATCHES WERE USED FOR THE ASSEMBLY GROUP OF THE CATHETER TUBE (INVOLVED CODE 6G35982002). THE VALUE OF THE TENSILE FORCE OF THE CATHETER TUBE FOR BATCH 8230223 WAS MIN. 8.24 N, FOR BATCH 8218804 MIN. 8.31 N. THEREFORE, BOTH BATCHES WERE WITHIN THEIR SPECIFICATION OF MIN. 3 N. THERE ARE TWO FURTHER COMPLAINTS FOR BATCH 8240947, AND 30 FURTHER COMPLAINTS FOR BATCH 8235019. HOWEVER, NONE OF THESE 30 FURTHER COMPLAINTS REGARDING A SNAPPED CATHETER WERE CONFIRMED. THERE WAS ONE FURTHER COMPLAINT REGARDING A SNAPPED CATHETER TUBE ON PRODUCT CODE 4G07125203 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

    PICC LEAKING AT 25CM POINT, PICC WAS REMOVED AND HAD TO BE REPLACED .

    Description of Event or Problem · 0

    PICC LEAKING AT 25CM POINT, PICC WAS REMOVED AND HAD TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618220 NUTRILINE INTRAVASCULAR CATHETER LJS VYGON USA 1252.030G 24G016D

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Unknown