BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 14981437 · Received July 11, 2022

    Report

    Report Number
    2245270-2022-00061
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Date of Event
    May 15, 2022
    Report Date
    October 14, 2022
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 MALFUNCTION WAS FIRST REPORTED TO FDA BY THE CUSTOMER VIA MEDWATCH 1000060000-2022-8029. WE RECEIVED ONE NUTRILINE CATHETER FOR EVALUATION. THE FAULTY SAMPLE RETURNED BY THE CUSTOMER WAS SHORTENED BY THE USER AT 14 CM. WHEN THE SAMPLE ARRIVED, A MICROCLAVE NEEDLEFREE CONNECTOR WAS ATTACHED AT ITS LUER LOCK HUB. DURING SAMPLE EXAMINATION WE FOUND THAT THE CATHETER WAS LEAKING NEXT TO THE FIXATION UPON THE ATTEMPT TO FLUSH IT WITH WATER USING A 10 ML SYRINGE. THERE WAS A MICROHOLE AT THE JUNCTION OF THE CATHETER WITH THE FIXATION WING. THE CATHETER TUBE WAS PARTLY TORN OUT OF THE FIXATION WING. MICROSCOPIC EXAMINATION OF THE FRACTURE PLANE SHOWED A ROUGH AND UNEVEN SURFACE, WHICH IS A TYPICAL SIGN FOR A TENSILE FRACTURE DUE TO A HIGH TENSILE LOAD. WE ALSO OBSERVED A SMALL INDENTATION AT 6 MM DISTAL TO THE FIXATION WING CAUSED BY SMALL MECHANICAL DAMAGE DURING OVERMOLDING. THIS WAS ONLY A SURFACE DAMAGE WITHOUT LEAKAGE. DOCUMENTATION SHOWED THAT THE CODE 4G31252400, BATCH 8132711 WAS USED TO MANUFACTURE THIS BATCH. AN INTERNAL PRODUCT RECALL (NO. 012, NON-CONFORMITY NO. 9424) WAS ISSUED MID-MARCH 2021. THE CATHETER TUBES WERE DAMAGED DURING THE INJECTION PROCESS BY A DEFECTIVE CLAMPING TOOL OF ONE OF THE TWO CAVITIES IN THE MOLD. THIS COULD CAUSE A MICRO-CRACK IN THE CATHETER TUBE. THE DEFECT OCCURRED ONLY AT A PRESSURE ABOVE 1.5 BAR. REGARDING THIS COMPLAINT, THE DEFECT WAS ONLY SUPERFICIAL AND CAUSED NO LEAK. IN THIS CASE IT IS ONLY A FAULT OF ASPECT. 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. 8132711) HAS A MEAN OF 5,51 N FOR THE BATCH INVOLVED. AT ITS MINIMUM AT 3 N, THIS IS WITHIN THE SPECIFICATION. VISUAL TESTS AND INCOMING GOODS INSPECTIONS ARE CARRIED OUT ON EACH CATHETER. AS EACH CATHETER IS LEAK AND FLOW TESTED BEFORE PACKAGING AND THE CATHETER WAS USED UNEVENTFULLY FOR 14 DAYS BEFORE LEAKAGE OCCURRED, WE DO NOT BELIEVE THIS DEFECT IS A MANUFACTURING RELATED. THEREFORE, NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT. CORRECTIVE ACTION: AS THE CATHETER HAS BEEN IN USE FOR 14 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

    PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE LEAKAGE AT THE HUB. A NEW PICC LINE WAS PLACED ON THE NEXT DAY WITHOUT INCIDENT.

    Description of Event or Problem · 0

    PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE LEAKAGE AT THE HUB. A NEW PICC LINE WAS PLACED ON THE NEXT DAY WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058833 NUTRILINE LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA 1252.35G 21F005D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other