BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE TWINFLO

    MDR report key: 21712558 · Received March 27, 2025

    Report

    Report Number
    2245270-2025-00031
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    February 17, 2025
    Report Date
    July 28, 2025
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K052475
    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 ONE USED CATHETER AS THE FAULTY SAMPLE, WITH ADDITIONAL NON-VYGON GERMANY GMBH EXTENSION LINES CONNECTED TO IT. THE CATHETER TUBE WAS SHORTENED AT THE 5 CM MARKING AND A SIGNIFICANT AMOUNT OF DRIED SOLUTION RESIDUE WAS VISIBLE. THE CATHETER SNAPPED BETWEEN THE BOLD END MARKING AND THE WING APPROX. 1.5 CM DISTAL TO THE WING. THE PROXIMAL FRACTURE SURFACE WAS STRAIGHT, AND SOME GROOVES WERE VISIBLE. THE DISTAL FRACTURE WAS DIAGONAL AND DID NOT ALIGN WITH THE PROXIMAL SURFACE, SUGGESTING THAT A PORTION OF THE CATHETER TUBE IS MISSING. THE EDGE OF THE CATHETER TUBE APPEARED SLIGHTLY WAVY, WITH VISIBLE GROOVES ON AN OTHERWISE SMOOTH SURFACE. THESE OBSERVATIONS INDICATE MECHANICAL DAMAGE, POSSIBLY COMBINED WITH TENSILE FORCE. IN GENERAL, THERE ARE VARIOUS EVENTS THAT CAN LEAD TO A SNAPPED 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. UNFORTUNATELY, THE CUSTOMER DID NOT SPECIFY WHETHER THE DISINFECTANT USED WAS WATER-BASED OR ALCOHOL-BASED. IN ADDITION, A MANUFACTURING FAULT CAN BE EXCLUDED SINCE THE CATHETER REMAINED INTACT FOR 50 DAYS, AS STATED BY THE CUSTOMER (INSERTED ON DEC. 29, 2024, AND REMOVED ON FEB. 17, 2025). IT IS IMPORTANT TO NOTE THAT THE CATHETER IS INTENDED FOR USE UP TO 29 DAYS, ACCORDING TO THE IFU. THE CUSTOMER USED THE CATHETER FOR 50 DAYS, WHICH IS BEYOND THE RECOMMENDED USAGE PERIOD. DOCUMENTATION REVIEW IS NOT POSSIBLE AS NO BATCH NUMBER WAS PROVIDED. EACH CATHETER UNDERGOES FLOW AND LEAK TESTING, AND THE TENSILE FORCE AND DIMENSIONS OF THE CATHETER AND SET COMPONENTS ARE RANDOMLY CHECKED DURING PRODUCTION. A 2-YEAR REVIEW OF VYGON USA'S COMPLAINT DATA SHOWS THAT TWO COMPLAINTS WERE REPORTED FOR PRODUCT CODE 1252.232M BETWEEN MARCH 1, 2023, AND MARCH 31, 2025, BOTH OF WHICH WERE LINKED TO THIS FACILITY. CORRECTIVE ACTION: SINCE THE CATHETER WORKED WELL FOR 50 DAYS BEFORE ITS SNAPPED, WE DO NOT BELIEVE THIS DEFECT IS MANUFACTURING RELATED. AS A RESULT, NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT AT THIS TIME. FURTHERMORE, THE CUSTOMER USED THE CATHETER WELL BEYOND THE INTENDED USE PERIOD, WHICH IS SPECIFIED IN THE IFU AS UP TO 29 DAYS. WE RECOMMEND FOLLOWING THE INTENDED USE AS SPECIFIED IN THE PRODUCT IFU.

    Description of Event or Problem · 0

    VYGON 2FR NUTRILINE TWINFLO CATHETER (PICC LINE) SNAPPED IN BETWEEN THE HUB AND THE LINE. DRESSING AND SAT LOCK WERE INTACT AND LINE WAS SECURE. THE PATIENT IS SAFE AND BEING CLOSELY MONITORED.

    Description of Event or Problem · 0

    VYGON 2FR NUTRILINE TWINFLO CATHETER (PICC LINE) SNAPPED IN BETWEEN THE HUB AND THE LINE. DRESSING AND SAT LOCK WERE INTACT AND LINE WAS SECURE.THE PATIENT IS SAFE AND BEING CLOSELY MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2658643 NUTRILINE TWINFLO INTRAVASCULAR CATHETER LJS VYGON USA 1252.232M UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown