BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 18588563 · Received January 26, 2024

    Report

    Report Number
    2245270-2024-00009
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Date of Event
    December 16, 2023
    Report Date
    March 19, 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). 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. THERE ARE VARIOUS EVENTS THAT CAN LEAD TO A CATHETER LEAKAGE/TENSILE FORCE: 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 IN BABIES. 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. THERE IS A STATEMENT IN OUR PRODUCT'S IFU: "BE AWARE THAT ORGANIC SOLVENTS SUCH AS ALCOHOL OR ACETONE MAY INTERACT WITH CATHETER MATERIAL AND WEAKEN IT." AND "AVOID ANY CONTACT OF THE CATHETER TUBING TO ALCOHOL CONTAINING DISINFECTANTS. THIS MAY IRREVERSIBLY DAMAGE THE CATHETER. A REVIEW OF THE BATCH HISTORY RECORDS WAS PERFORMED FOR 8191954, 8208322 & 8212767, AND NO DEVIATIONS WERE FOUND. EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION. THE TENSILE FORCE AND DIMENSIONS OF THE CATHETER/SET COMPONENTS IS RANDOMLY CHECKED. THE BATCHES COMPLIED WITH ITS SPECIFICATIONS AND WERE RELEASED. THERE ARE TWO FURTHER COMPLAINTS FOR COMPONENT BATCH 8212767, ONE FURTHER COMPLAINT FOR BATCH 8208322, THREE FURTHER COMPLAINTS FOR BATCH 8191954 WITHIN THE LAST THREE YEARS. THIS QUERY RELATES TO ALL THE COMPLAINTS THAT HAVE COME TO OUR ATTENTION WORLDWIDE. CORRECTIVE ACTION: 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. THEREFORE, NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT.

    Additional Manufacturer Narrative · 0

    THIS MALFUNCTION WAS FIRST REPORTED TO FDA BY THE CUSTOMER VIA (B)(4). THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED WITH FDA WITHIN 30 DAYS OF COMPLETION.

    Description of Event or Problem · 0

    FLUID LEAKING FROM THE HUB OF PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE.

    Description of Event or Problem · 0

    FLUID LEAKING FROM THE HUB OF PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121124 NUTRILINE LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA 1252.030G 23I009D

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Female