BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 16853808 · Received May 2, 2023

    Report

    Report Number
    2245270-2023-00029
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    April 4, 2023
    Report Date
    July 12, 2023
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MALFUNCTIONING DEVICE WILL BE RETURNED TO VYGON FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. 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 SAMPLE WAS SENT TO THE STERILIZATION SITE FOR FURTHER PROCESSING. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING.

    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 USED NUTRILINE CATHETER AS A SAMPLE. THE 30 CM NUTRILINE CATHETER RETURNED BY THE CUSTOMER WAS SHORTENED BY THE USER AT THE 7 CM MARKING. THE CATHETER SHOWED MANY FIBRIN INCRUSTATIONS ALONG THE CATHETER. UPON FLUSHING THE CATHETER LEAKED AT THE JUNCTION OF THE CATHETER WITH THE FIXATION WING. MICROSCOPIC EXAMINATION SHOWED A HOLE AND STRETCHED MATERIAL WITH STRESS WHITENING, WHICH IS A TYPICAL SIGN OF TENSILE ELONGATION DUE TO A HIGH TENSILE LOAD. A REVIEW OF THE BATCH HISTORY RECORDS FOR 8172410 AND 81911954 WAS PERFORMED, AND NO DEVIATIONS FROM SPECIFICATIONS WERE FOUND. THE BATCHES COMPLIED WITH ITS SPECIFICATIONS AND WERE RELEASED. EACH CATHETER IS LEAK AND FLOW TESTED DURING PRODUCTION. THE TENSILE FORCE OF THE CATHETER COMPONENTS IS RANDOMLY CHECKED. VISUAL TESTS ARE CARRIED OUT FOR PRODUCT/COMPONENT PRESENCE, THE PRESENCE IN CAVITIES, AND THE INTEGRITY OF THE PRODUCT SEAL. THIS IS THE FIRST COMPLAINT RECEIVED FOR BATCH NO. 8191954. WE ALSO RECEIVED THREE COMPLAINTS FOR BATCH NO. 8172410 IN TOTAL AND EIGHTEEN COMPLAINTS REGARDING A LEAKING CATHETER TUBE AT THE JUNCTION OF THE CATHETER AND THE FIXATION WING ON CODE 4G07125203 WERE RECEIVED WITHIN THE LAST THREE YEARS, BUT NONE OF THEM WERE MANUFACTURING-RELATED. MOST OF THEM WERE RELATED TO THE HIGH TENSILE FORCE OR THE USE OF ALCOHOL-BASED DISINFECTANTS. THIS QUERY COVERS ALL COMPLAINTS THAT HAVE COME TO OUR ATTENTION WORLDWIDE. CORRECTIVE ACTION: AS EACH CATHETER IS LEAK AND FLOW TESTED BEFORE PACKAGING AND THE CATHETER WORKED WELL FOR SEVERAL DAYS (MANY FIBRIN INCRUSTATIONS), A MANUFACTURING DEFECT IS RATHER UNLIKELY. ANY MANUFACTURING PROBLEMS THAT WOULD LEAD TO A LEAK WOULD BE DETECTED BY THE USER WHEN FLUSHING THE CATHETER. THEREFORE, NO FURTHER CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME. ADDITIONALLY, THERE IS A STATEMENT IN THE PRODUCT'S IFU, IMPORTANT CAUTIONS: "DO NOT OVER STRETCH THE CATHETER AS IT MAY RUPTURE, CAUSING A CATHETER EMBOLISM".

    Description of Event or Problem · 0

    PICC DRESSING FOUND BLOODY DRAINAGE: UPON FURTHER INSPECTION DURING DRESSING CHANGE LINE FOUND TO BE DRIPPING (LEAKING) AT THE WINGS.

    Description of Event or Problem · 0

    PICC DRESSING FOUND BLOODY DRAINAGE: UPON FURTHER INSPECTION DURING DRESSING CHANGE LINE FOUND TO BE DRIPPING (LEAKING) AT THE WINGS.

    Description of Event or Problem · 0

    PICC DRESSING FOUND BLOODY DRAINAGE: UPON FURTHER INSPECTION DURING DRESSING CHANGE LINE FOUND TO BE DRIPPING (LEAKING) AT THE WINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123634 NUTRILINE LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA 1252.030G 23A001D

    Patients

    Seq Age Sex Outcome Treatment
    1 28 DA Female