BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICATH

    MDR report key: 10656257 · Received October 9, 2020

    Report

    Report Number
    2245270-2020-00093
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    August 19, 2020
    Report Date
    November 13, 2020
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K954302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    WE RECEIVED THREE SAMPLES FOR THIS COMPLAINT: 2 PREMICATHS AND ONE NUTRILINE. WHEN TESTED, ALL SAMPLES WERE IMMEDIATELY LEAKING AT THE JUNCTION OF CATHETER TUBE AND EXTENSION LINE/WING WHEN FLUSHING THEM. MICROSCOPIC EXAMINATION CONFIRMED A LITTLE RADIAL TEAR AND SHOWED THAT EACH CATHETER TUBE WAS PARTLY TORN OUT OF THE JUNCTION TO THE EXTENSION LINE/FIXATION WING. FROM PREVIOUS COMPLAINTS WE LEARN OF VARIOUS POSSIBLE CAUSES OF LEAKAGES AT THE JUNCTION OF CATHETER TUBE AND EXTENSION LINE/WING FROM THE PAST. MOST OF THEM WERE RELATED TO TENSILE TRACTION UNDER INFLUENCE OF THE USE OF ALCOHOL-BASED DISINFECTANTS. WE GOT INFORMED THAT CHLORAPREP HAD BEEN USED AS DISINFECTANT WHICH CONTAINS 70% ALCOHOL. 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. IF AN ALCOHOL-BASED DISINFECTANT IS USED ON THE INSERTION SKIN AREA, IT MUST DRY COMPLETELY BEFORE EXPOSING THE CATHETER TO ANY MECHANICAL STRESS." THE PRODUCT'S IFU ALSO SPECIFICALLY SUGGESTS: "CAREFULLY CLEAN THE INSERTION SITE AND POSITION DRAPES. THE PUNCTURE MAY ONLY BE MADE AFTER THE DISINFECTANT HAS BEEN COMPLETELY DRIED ON THE SKIN. 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 SHOWED NO DEVIATIONS. EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION. THE TENSILE FORCE OF THE CATHETER COMPONENTS IS RANDOMLY CHECKED. INCOMING GOODS INSPECTIONS AND TWO 100% VISUAL TESTS ARE PERFORMED AFTER PRODUCT IS PACKAGED. THIS IS THE FOURTH COMPLAINT FOR THE INVOLVED BATCHES 8082677 AND 8090698 AND THE THIRD REGARDING CA LEAKING CATHETER TUBE ON CODE 4G07126120 WITHIN THE LAST THREE YEARS. AS THE CATHETER WORKED WELL FOR 13 DAYS AND 37 DAYS, WE DO NOT BELIEVE THIS IS A MANUFACTURING FAULT AND NO FURTHER CORRECTIVE ACTION IS INITIATED BY QUALITY MANAGEMENT. CORRECTIVE ACTION: BASED ON THE INVESTIGATION, THIS ISSUE COULD NOT BE DETERMINED TO BE CAUSED BY MANUFACTURING; THEREFORE, NO FURTHER CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME. BOTH VYGON USA AND GERMANY WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    THEY WERE FOUND TO BE LEAKING FROM THE SAME SPOT, THE LOCATION BETWEEN THE CATHETER AND THE BUTTERFLY.

    Additional Manufacturer Narrative · 1

    TWO OCCURRENCES OF THIS MALFUNCTION WERE REPORTED TO VYGON, THE DETAILS OF THE OTHER CAN BE FOUND IN MDR 2245270-2020-00092. SAMPLES WILL BE RETURNED TO VYGON AND WILL BE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED WITH FDA WITHIN 30 DAYS OF COMPLETION.

    Description of Event or Problem · 1

    THEY WERE FOUND TO BE LEAKING FROM THE SAME SPOT, THE LOCATION BETWEEN THE CATHETER AND THE BUTTERFLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122042 PREMICATH LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA 1261.20G 19L003D

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR