BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 15221612 · Received August 12, 2022

    Report

    Report Number
    2245270-2022-00073
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    May 28, 2022
    Report Date
    December 5, 2022
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MALFUNCTION WAS FIRST REPORTED TO FDA BY THE CUSTOMER VIA MEDWATCH (B)(4). THE FAILED DEVICE WILL BE RETURNED TO VYGON FOR EVALUATION AND 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

    THIS COMPLAINT CANNOT BE CLASSIFIED AS NO FAULTY SAMPLE WAS RECEIVED FROM THE HOSPITAL. DUE TO THE MISSING SAMPLE AND FURTHER INFORMATION, THE ROOT CAUSE OF THIS ISSUE COULD NOT BE CONFIRMED. NO INFORMATION IS PROVIDED REGARDING THE CONDITIONS OF USE (TIME OF USE, DETAILS OF ANY MEDICATION/INFUSION ADMINISTERED THROUGH THE PRODUCT. WE WERE NOT INFORMED WHAT KIND OF DISINFECTANT WAS USED BY THE CUSTOMER. 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. FROM PREVIOUS COMPLAINTS WE LEARN OF VARIOUS POSSIBLE CAUSES OF A CATHETER LEAKAGE: · MECHANICAL DAMAGE BY A SHARP INSTRUMENT (FOR EXAMPLE SCALPEL) DURING DRESSING CHANGE. · 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 RESULTING IN A TENSILE FRACTURE · ROUTINE CARE - WHEN LIFTING THE BABY TO CHANGE BEDDING · MOVEMENT - THE BABY THEMSELVES CATCHING THE LINE, NORMALLY WITH A FOOT, DURING MOVEMENT EACH CATHETER IS LEAK AND FLOW TESTED DURING PRODUCTION. THE TENSILE FORCE OF THE CATHETER COMPONENTS IS RANDOMLY CHECKED. THE TENSILE FORCE FOR THE JUNCTION OF CATHETER TUBE AND WING (CODE (B)(4). , BATCH NO. 8132711 HAS A MEAN OF 5,51 N FOR THE BATCH INVOLVED. CODE (B)(4). , BATCH NO. 8111097 HAS A MEAN OF 4,98 N. AT ITS MINIMUM AT 3 N, THIS IS WITHIN THE SPECIFICATION. VISUAL TESTS AND INCOMING GOODS INSPECTIONS ARE CARRIED OUT WITH NO EXEMPTIONS FOUND. THE BATCH COMPLIED TO ITS SPECIFICATION AND WAS RELEASED. A REVIEW OF THE BATCH HISTORY RECORDS WAS PERFORMED, AND NO DEVIATIONS WERE FOUND. EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION. THE TENSILE FORCE OF THE CATHETER COMPONENTS IS RANDOMLY CHECKED. VISUAL TESTS AND INCOMING GOODS INSPECTIONS ARE CARRIED OUT. CORRECTIVE ACTION: DUE TO THE MISSING SAMPLE AND FURTHER INFORMATION, THE ROOT CAUSE OF THIS ISSUE COULD NOT BE CONFIRMED. NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT.

    Description of Event or Problem · 0

    LEAKAGE OCCURRED AT WING SITE. THE DEVICE HAD TO BE REMOVED AND REPLACED.

    Description of Event or Problem · 0

    LEAKAGE OCCURRED AT WING SITE. THE DEVICE HAD TO BE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237569 NUTRILINE LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA 1252.35G 21D014D

    Patients

    Seq Age Sex Outcome Treatment
    1 2 WK Male