BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 12989501 · Received December 13, 2021

    Report

    Report Number
    2245270-2021-00124
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 5, 2021
    Report Date
    January 10, 2022
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH NO DEVICE WAS RETURNED FOR EVALUATION, THE DETAILS OF THE MALFUNCTION WILL BE EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 0

    WE RECEIVED THE CATHETER AS A SAMPLE. THE CATHETER TUBE WAS SHORTENED TO APPROX. 19 CM. FLUSHING THE CATHETER SHOWS A LEAKAGE AT THE FIXATION WING BUT DOESN'T RESULT IN A FLOW THROUGH THE DISTAL TIP AS THE CATHETER IS SEVERELY OCCLUDED. THE MICROSCOPIC EXAMINATION SHOWS THAT THE CATHETER TUBE WAS PARTLY TORN OUT AT THE JUNCTION OF THE CATHETER AND FIXATION WING. THE SURFACE OF THE BROKEN AREA IS ROUGH, WHICH IS A TYPICAL SIGN FOR THE EFFECT OF EXCESSIVE TENSILE STRESS. SEE PHOTOS. WE WERE NOT INFORMED WHAT KIND OF DISINFECTANT WAS USED BY THE CUSTOMER. 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. FROM PREVIOUS COMPLAINTS WE LEARN OF VARIOUS POSSIBLE CAUSES OF A TENSILE FRACTURE: · DRESSING CHANGE - IN SOME INSTANCES THE CATHETER CAN BECOME ADHERED TO THE DRESSING AND ADDITIONAL PULLING IS REQUIRED TO FREE IT, PLACING STRESS ON THE LINE RESULTING IN A TENSILE FRACTURE · ROUTINE CARE - WHEN LIFTING THE BABY TO CHANGE BEDDING · MOVEMENT - THE BABY THEMSELVES CATCHING THE LINE, NORMALLY WITH A FOOT, DURING MOVEMENT A REVIEW OF THE BATCH HISTORY RECORDS WAS PERFORMED, AND NO DEVIATIONS. 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. THERE HAVE BEEN TWO ADDITIONAL COMPLAINTS FOR BATCHES 8131566 AND 8134052 AND THERE ARE THREE ADDITIONAL COMPLAINTS REGARDING A LEAKING CATHETER AT THE JUNCTION IN CODE 4G07125203 WITHIN THE LAST THREE YEARS FOR THE SAME CUSTOMER. CORRECTIVE ACTION: NO FURTHER CORRECTIVE ACTION INITIATED BY QUALITY MANAGEMENT DUE TO THIS COMPLAINT, AS THERE ARE NO INDICATIONS OF A MANUFACTURING ROOT CAUSE.

    Description of Event or Problem · 0

    PICC LINE BROKE BELOW BUTTERFLY. LEAKING.

    Description of Event or Problem · 0

    PICC LINE BROKE BELOW BUTTERFLY. LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880071 NUTRILINE LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA 1252.030G 21D011D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown