BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 14731077 · Received June 17, 2022

    Report

    Report Number
    2245270-2022-00046
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    January 14, 2022
    Report Date
    October 13, 2022
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE FAILED SAMPLE WILL BE RETURNED TO VYGON FOR EVALUATION AS PART OF THE 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

    THE COMPLAINT WAS FORWARDED TO OUR PARENT COMPANY IN GERMANY FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: DUE TO THE MISSING SAMPLE, THE ROOT CAUSE OF THIS ISSUE COULD NOT BE CONFIRMED. THIS COMPLAINT CANNOT BE CLASSIFIED AS NO FAULTY SAMPLE WAS RECEIVED FROM THE HOSPITAL. HOWEVER, WE RECEIVED A SIMILAR COMPLAINT FROM THIS HOSPITAL, WHERE THE CATHETER WAS PARTY TORN OUT OF THE FIXATION WING AND THEREFORE STARTED TO LEAK. (B)(4). A REVIEW OF THE BATCH HISTORY RECORDS WAS PERFORMED, AND NO DEVIATIONS WERE FOUND. THE BATCH COMPLIED TO ITS SPECIFICATION AND WAS RELEASED. 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 4G31252400, BATCH NO. 8121285) HAS A MEAN OF 4,93 N FOR THE BATCH INVOLVED. AT ITS MINIMUM AT 3 N, THIS FIGURE IS WITHIN THE SPECIFICATION. NO INCREASE IN SCRAP WAS SEEN DURING LEAK TEST OF CODE 4G31252400, BATCH NUMBER 8121285. CODE 4G31252400 WAS USED TO MANUFACTURE THIS BATCH. THIS IS THE PART OF PRODUCTION WHERE THE LEAK AND FLOW TESTS ARE DONE. IF THERE IS A MANUFACTURING PROBLEM REGARDING CATHETER LEAKAGE, WE WOULD HAVE SEEN AN INCREASE IN SCRAP DURING TESTS. VISUAL TESTS AND INCOMING GOODS INSPECTIONS ARE CARRIED OUT WITH NO EXCEPTIONS FOUND. CORRECTIVE ACTION: NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT AS DUE TO THE MISSING SAMPLE AND THE CATHETER WAS USED UNEVENTFULLY FOR 4 DAYS BEFORE LEAKAGE OCCURRED. THEREFORE, IT IS NOT LIKELY THAT THE LEAK REPORTED WAS A RESULT OF A MANUFACTURING DEFECT.

    Description of Event or Problem · 0

    BREAK/LEAK.

    Description of Event or Problem · 0

    BREAK/LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189940 NUTRILINE LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA 1252.030G 21H028D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown