BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 14731112 · Received June 17, 2022

    Report

    Report Number
    2245270-2022-00045
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    February 13, 2022
    Report Date
    September 13, 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 ONE SAMPLE FOR EVALUATION. THE RECEIVED SAMPLE WAS SHORTENED AT ITS 17 CM MARKING. WHEN FLUSHING THE CATHETER WITH WATER, NO LEAKAGE OCCURRED BUT WHEN TESTED IN A WATER BATH, LEAKAGE WAS DETECTED WHEN AIR WAS INJECTED. USING HIGHER PRESSURE, THE CATHETER ALSO LEAKED WITH WATER AT THE JUNCTION OF THE CATHETER TUBE WITH THE FIXATION WING AFTER BLOCKING THE TIP. MICROSCOPIC EXAMINATION SHOWED THAT THE CATHETER TUBE WAS INDEED PARTLY TORN OUT OF THE FIXATION WING. TYPICAL SIGNS OF A ROUGH AND UNEVEN FRACTURE PLANE 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 FOR CODE 4G31252400, BATCH NO. 8111860) HAS A MEAN OF 5,13 N FOR THE BATCH INVOLVED. FOR BATCH NO 8121285 THE MEAN WAS 4,93 N. AT ITS MINIMUM AT 3 N, BOTH FIGURES ARE WITHIN THE SPECIFICATION. VISUAL TESTS AND INCOMING GOODS INSPECTIONS ARE CARRIED OUT WITH NO EXCEPTIONS FOUND. 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. AS EACH CATHETER IS LEAK AND FLOW TESTED BEFORE PACKAGING AND THE CATHETER WAS USED WITHOUT PROBLEMS FOR 3 DAYS BEFORE LEAKAGE OCCURRED, WE DO NOT BELIEVE THIS DEFECT IS A MANUFACTURING RELATED. IN ADDITION, THE PRODUCT INCIDENT REPORT (PIR) STATES STATSEAL DISCS AS HEMOSTATIC PATCHES WERE USED WITH THIS CATHETER. ACCORDING TO THE STATSEAL IFU IT IS USED AT THE CATHETER'S PROXIMAL END. WE SUSPECT THAT THIS MAY HAVE CONTRIBUTED TO THE EXTRA TRACTION ON THE CATHETER TUBE PRODUCED BY THE STATSEAL DISC. CORRECTIVE ACTION: AS THE CATHETER HAS BEEN IN USE FOR 3 DAYS, WE DO NOT BELIEVE THIS DEFECT IS A MANUFACTURING RELATED. EACH CATHETER IS LEAK AND FLOW TESTED BEFORE PACKAGING. ANY MANUFACTURING PROBLEMS THAT WOULD LEAD TO A LEAK WOULD BE DETECTED BY THE USER WHEN FLUSHING THE CATHETER. THEREFORE, NO FURTHER CORRECTIVE ACTION IS INITIATED BY QUALITY MANAGEMENT THIS FAILURE WILL BE MONITORED FOR FUTURE ACTIONS.

    Description of Event or Problem · 0

    LEAK/BROKE.

    Description of Event or Problem · 0

    LEAK/BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194865 NUTRILINE LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA 1252.030G 21D011D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown