BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 15234917 · Received August 16, 2022

    Report

    Report Number
    2245270-2022-00078
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    July 19, 2022
    Report Date
    January 26, 2023
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THIS INVESTIGATION ARE PENDING AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION VIA FOLLOW UP MDR.

    Additional Manufacturer Narrative · 0

    THE FAULTY SAMPLE WAS DISCARDED BY THE USER, HOWEVER THE CUSTOMER RETURNED ONE UNOPENED SAMPLE FROM THE SAME BATCH. THE SAMPLE WAS LEAK TESTED AT 1.5 BAR, AND NO LEAKAGE WAS DETECTED. WE FLUSHED THE CATHETER USING A 10 ML SYRINGE WITH SALINE FIRST AND THEN AIR IN A WATER BATH, BUT NO LEAKAGE WAS DETECTED. DURING MICROSCOPIC EXAMINATION WE SAW 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. BASED ON THE PRODUCT INCIDENT REPORT (PIR), THE CUSTOMER USED ALCOHOL BASED CHLORAPREP AS A DISINFECTANTS. 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. MOREOVER, WE HAVE A WARNING LEAFLET IN EACH BLISTER WHICH DECLARES: "NEVER USE ORGANIC SOLVENTS SUCH AS ALCOHOL DIRECTLY ON THE CATHETER, IT MAY WEAKEN THE MATERIAL. 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. THE TENSILE FORCE FOR THE JUNCTION OF CATHETER TUBE AND WING (CODE (B)(4), BATCH NO. 8132711 HAS A MEAN OF 5,51 N. THE MEAN FOR BATCH NO. 8145987 WAS 5,28 N. AT ITS MINIMUM AT 3 N, THESE TEST RESULTS ARE WITHIN THE SPECIFICATION. VISUAL TESTS AND INCOMING GOODS INSPECTIONS ARE CARRIED OUT WITH NO EXCEPTIONS FOUND. CORRECTIVE ACTION: NO FURTHER CORRECTIVE ACTION INITIATED BY QUALITY MANAGEMENT DUE TO THIS COMPLAINT, AS THE FAULTY SAMPLE WAS DISCARDED BY THE USER AND THE CATHETER WAS USED UNEVENTFULLY FOR 20 DAYS BEFORE LEAKAGE OCCURRED, A MANUFACTURING DEFECT WOULD BE RATHER UNLIKELY. ANY MANUFACTURING PROBLEMS THAT WOULD LEAD TO A LEAK WOULD BE DETECTED BY THE USER WHEN FLUSHING THE CATHETER.

    Description of Event or Problem · 0

    PICC LINE NOTED TO BE LEAKING AT FLANGE.

    Description of Event or Problem · 0

    PICC LINE NOTED TO BE LEAKING AT FLANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2790450 NUTRILINE LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA 1252.30G 22A020D

    Patients

    Seq Age Sex Outcome Treatment
    1 24 DA Female