BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 18734251 · Received February 19, 2024

    Report

    Report Number
    2245270-2024-00020
    Event Type
    Malfunction
    Date Received
    February 19, 2024
    Date of Event
    January 12, 2024
    Report Date
    May 20, 2024
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MALFUNCTION WAS FIRST REPORTED TO FDA BY THE CUSTOMER VIA MEDWATCH (B)(4)THE DEVICE HAS NOT YET BEEN RETURNED TO VYGON, BUT THE COMPLAINT DETAILS HAVE BEEN SENT TO VYGON GMBH FOR COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION.

    Additional Manufacturer Narrative · 0

    WE CONTACTED THE CUSTOMER AND ASKED FOR MORE DETAILS ABOUT THE INCIDENT. THE CUSTOMER HAS INFORMED US THAT THE DEFECTIVE PRODUCT WAS DISPOSED OF AFTER IT FAILED. DUE TO THE ABSENCE OF THE DEFECTIVE SAMPLE AND ADDITIONAL DETAILS, THIS COMPLAINT CANNOT BE CONFIRMED, AND THE EXACT ROOT OF THE ISSUE CANNOT BE DETERMINED. HOWEVER, THE MEDWATCH REPORT INDICATED THAT THE DEVICE WAS APPROXIMATELY 45 DAYS OLD, SO WE DO NOT BELIEVE THIS DEFECT IS RELATED TO MANUFACTURING. THERE ARE VARIOUS POSSIBLE CAUSES THAT CAN LEAD TO CATHETER LEAKAGE/TENSILE FRACTURE: 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. MECHANICAL DAMAGE BY A SHARP INSTRUMENT (FOR EXAMPLE SCISSORS, TOOTHED FORCEPS, OR SCALPEL) DURING DRESSING CHANGE. USE OF ALCOHOL-BASED DISINFECTANT. A REVIEW OF THE BATCH HISTORY RECORDS WAS PERFORMED FOR COMPONENT LOTS 8191954, 8208322, AND 8212767, AND NO DEVIATIONS WERE FOUND. EACH CATHETER IS FLOW AND LEAK-TESTED DURING PRODUCTION. THE BATCHES COMPLIED WITH ITS SPECIFICATIONS AND WERE RELEASED. THE TENSILE FORCE AND DIMENSIONS OF THE CATHETER COMPONENTS ARE RANDOMLY CHECKED. INCOMING GOODS INSPECTIONS AND TWO 100% VISUAL TESTS AFTER PACKAGING ARE CARRIED OUT WITH NO EXEMPTIONS FOUND. A REVIEW OF THE VYGON USA DATABASE INDICATES THAT THIS IS THE SECOND COMPLAINT RECEIVED FOR PRODUCT LOT NUMBER 23I0009D. CORRECTIVE ACTION: THIS COMPLAINT COULD NOT BE CLASSIFIED DUE TO THE MISSING SAMPLE AND FURTHER INFORMATION. THEREFORE, NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT.

    Description of Event or Problem · 0

    UPON DOING A PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) DRESSING CHANGE, THE RN (REGISTERED NURSE) NOTED LEAKING FROM WHERE THE DEVICE HUB AND CATHETER MEET. THE LINE WAS REMOVED PER MD (MEDICAL DOCTORS'S) ORDER.

    Description of Event or Problem · 0

    UPON DOING A PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) DRESSING CHANGE, THE RN (REGISTERED NURSE) NOTED LEAKING FROM WHERE THE DEVICE HUB AND CATHETER MEET. THE LINE WAS REMOVED PER MD (MEDICAL DOCTORS'S) ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528551 NUTRILINE INTRAVASCULAR CATHETER LJS VYGON USA 1252.030G 23I009D

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male