BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 14695911 · Received June 15, 2022

    Report

    Report Number
    2245270-2022-00040
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    June 6, 2022
    Report Date
    September 9, 2022
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K051690
    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: WE RECEIVED A COMPLETE NUTRILINE CATHETER WITH A MICROCLAVE NEEDLE FREE CONNECTOR MOUNTED ON ITS LUER LOCK HUB. UPON FLUSHING THE CATHETER WITH WATER, THE CATHETER TUBE WAS PARTLY BLOCKED, BUT IMMEDIATE LEAKAGE WAS SEEN ON THE JUNCTION OF THE CATHETER TUBE WITH THE FIXATION WING. MICROSCOPIC EXAMINATION SHOWED THAT THE CATHETER TUBE WAS INDEED PARTLY TORN OUT OF THE FIXATION WING. TYPICAL SIGNS OF A ROUGH AND UNEVEN PLANE OF FACTURE AND SOME STRESS WHITENING ARE VISIBLE. 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. 8141374) HAS A MEAN OF 5,32 N FOR THE BATCH INVOLVED. FOR BATCH, NUMBER 8121285 THE MEAN WAS 4,93 N. AT ITS MINIMUM AT 3 N, BOTH FIGURES ARE WITHIN THE SPECIFICATION. NO INCREASE IN SCRAP WAS SEEN DURING LEAK TEST OF CODE 4G31252400, BATCH NO. 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. NO FURTHER CORRECTIVE ACTION INITIATED BY QUALITY MANAGEMENT AS THERE ARE NO INDICATIONS OF A MANUFACTURING DEFECT. CORRECTIVE ACTION: NO FURTHER CORRECTIVE ACTION INITIATED BY QUALITY MANAGEMENT DUE TO THIS COMPLAINT, AS THERE ARE NO INDICATIONS OF A MANUFACTURING FAULT. IT IS HIGHLY RECOMMENDED TO READ THE WARNING LEAFLET INSERTED INTO EACH PACKAGING CONCERNING THE USE OF ALCOHOL OR ORGANIC SOLVENTS WITH THIS CATHETER.

    Description of Event or Problem · 0

    LEAK/BREAK-LEAKING FROM JUNCTION WING & LINE PROXIMAL TO PATIENT.

    Description of Event or Problem · 0

    LEAK/BREAK-LEAKING FROM JUNCTION WING & LINE PROXIMAL TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847740 NUTRILINE LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA 1252.030G 21K029D

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Female