BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 16368286 · Received February 13, 2023

    Report

    Report Number
    2245270-2023-00011
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    December 31, 2023
    Report Date
    March 10, 2023
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS FORWARDED TO OUR PARENT COMPANY IN GERMANY FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: THE FAILED SAMPLE WAS NOT RETURNED BY THE USER; HOWEVER, THE USER SENT A PHOTO OF THE FAILED DEVICE. EXAMINATION OF THE RETURNED PHOTO CLEARLY SHOWED THAT THE CATHETER TUBE WAS PARTLY TORN FROM THE FIXATION WING. BASED ON THE PRODUCT INCIDENT REPORT (PIR), THE CUSTOMER USED ALCOHOL-BASED 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. A REVIEW OF THE BATCH HISTORY RECORDS FOR 8171598, AND 8172410 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. VISUAL TESTS AND INCOMING GOODS INSPECTIONS ARE CARRIED OUT. THE BATCH COMPLIED TO ITS SPECIFICATION AND WAS RELEASED. CORRECTIVE ACTION: DUE TO THE MISSING SAMPLE, THE ROOT CAUSE OF THIS ISSUE COULD NOT BE CONFIRMED. THEREFORE, NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT AT THIS TIME.

    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.

    Description of Event or Problem · 0

    "BABY'S PICC LINE DRESSING NOTED TO BE LIFTING. EDGES OF DRESSING NOTED TO HAVE SOME FLUID ON IT CONTRIBUTING TO THE LIFTING OF THE DRESSING. INITIALLY BELIEVED TO BE SOLELY D/T LEAKAGE OF FLUID AROUND BABY'S SILO, HOWEVER ONCE PICC DRESSING REMOVED FOR DRESSING CHANGE THE SITE WAS NOTED TO NOT BE DRYING. LEUKOSTRIPS WOULD NOT STICK AS THEY BECAME SATURATED. WRITER AND CHARGE RN NOTING DROPLETS FORMING FROM AREA THAT PICC LINE CONNECTS TO WINGED AREA OF LINE. PHYSICIAN CALLED TO BEDSIDE, NEW DRESSING PLACED. NEW PICC LINE HAD TO BE INSERTED AS OLD LINE WAS CONFIRMED TO BE LEAKING. WHILE WRITER PRIMING NEW LINES FOR NEW PICC PRIOR TO ATTACHING LINES THE OLD PICC LINE WAS NOTED TO HAVE ACTUALLY SLID OUT ON ITS OWN FROM UNDERNEATH THE NEW DRESSING DUE TO IT BECOMING SATURATED VERY QUICKLY. PHYSICIAN CALLED TO BEDSIDE ONCE AGAIN AND ASSISTING WRITER IN FULLY REMOVING OLD LINE."

    Description of Event or Problem · 0

    "BABY'S PICC LINE DRESSING NOTED TO BE LIFTING. EDGES OF DRESSING NOTED TO HAVE SOME FLUID ON IT CONTRIBUTING TO THE LIFTING OF THE DRESSING. INITIALLY BELIEVED TO BE SOLELY D/T LEAKAGE OF FLUID AROUND BABY'S SILO, HOWEVER ONCE PICC DRESSING REMOVED FOR DRESSING CHANGE THE SITE WAS NOTED TO NOT BE DRYING. LEUKOSTRIPS WOULD NOT STICK AS THEY BECAME SATURATED. WRITER AND CHARGE RN NOTING DROPLETS FORMING FROM AREA THAT PICC LINE CONNECTS TO WINGED AREA OF LINE. PHYSICIAN CALLED TO BEDSIDE, NEW DRESSING PLACED. NEW PICC LINE HAD TO BE INSERTED AS OLD LINE WAS CONFIRMED TO BE LEAKING. WHILE WRITER PRIMING NEW LINES FOR NEW PICC PRIOR TO ATTACHING LINES THE OLD PICC LINE WAS NOTED TO HAVE ACTUALLY SLID OUT ON ITS OWN FROM UNDERNEATH THE NEW DRESSING DUE TO IT BECOMING SATURATED VERY QUICKLY. PHYSICIAN CALLED TO BEDSIDE ONCE AGAIN AND ASSISTING WRITER IN FULLY REMOVING OLD LINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654017 NUTRILINE LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA 1252.030G 22H009D

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Male