BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICATH

    MDR report key: 20049091 · Received August 23, 2024

    Report

    Report Number
    2245270-2024-00070
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    August 1, 2024
    Report Date
    October 17, 2024
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K041468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MALFUNCTIONING DEVICE WAS RETURNED TO THE MANUFACTURER AND UPON RECEIPT, AN INVESTIGATION WILL BE CONDUCTED. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING,AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION.

    Additional Manufacturer Narrative · 0

    WE RECEIVED ONE USED CATHETER CONNECTED TO AN NFD NEEDLE-FREE DEVICE AND ADDITIONAL NON VYGON GMBH PRODUCT AS A FAULTY SAMPLE. THE CATHETER TUBE HAD BEEN SHORTENED TO THE 4 CM MARK. THE ATTEMPT TO FLUSH THE CATHETER WITH WATER WAS SUCCESSFUL, BUT A LEAKAGE WAS DETECTED AT THE JUNCTION BETWEEN THE CATHETER TUBE AND EXTENSION LINE. MICROSCOPIC EXAMINATION REVEALED A TEAR INSIDE THE CATHETER TUBE. THE FRACTURE SURFACE WAS VERY ROUGH AND JAGGED INDICATING THAT EXCESSIVE TENSILE FORCES WERE APPLIED, AND THAT ALCOHOL-BASED DISINFECTION WAS USED. THERE ARE VARIOUS EVENTS THAT CAN LEAD A LEAKING CATHETER: TENSILE FORCE. WHICH MAY BE CAUSED BY: 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 COULD RESULT IN A TENSILE FRACTURE. FOR BABIES, ROUTINE CARE (WHEN LIFTING THE BABY TO CHANGE THE BEDDING) AND MOVEMENT OF THE BABY ITSELF COULD RESULT IN A TENSILE FRACTURE. MECHANICAL DAMAGE BY A SHARP INSTRUMENT (FOR EXAMPLE SCISSORS, TOOTHED FORCEPS, OR SCALPEL) DURING DRESSING CHANGE. ALCOHOL-BASED DISINFECTANT. IN THE IFU IS ALSO STATED: BE AWARE THAT ORGANIC SOLVENTS SUCH AS ALCOHOL OR ACETONE MAY INTERACT WITH CATHETER MATERIAL AND WEAKEN IT. DO NOT BEND THE CATHETER OR THE EXTENSION LINE PERMANENTLY TO AVOID DAMAGE TO THE CATHETER. DO NOT OVER STRETCH THE CATHETER AS IT MAY RUPTURE, AND REBOUND INTO THE INSERTION SITE, CAUSING A CATHETER EMBOLISM. A REVIEW OF THE COMPONENT BATCH HISTORY RECORDS WAS PERFORMED, AND NO DEVIATIONS WERE FOUND. THE BATCH COMPLIED WITH ITS SPECIFICATIONS AND WAS RELEASED. EACH CATHETER IS FLOW AND LEAK-TESTED DURING PRODUCTION. THE TENSILE FORCE AND DIMENSIONS OF THE CATHETER AND SET COMPONENTS ARE RANDOMLY CHECKED. INCOMING GOODS INSPECTIONS AND TWO 100% VISUAL TESTS AFTER PACKAGING ARE CONDUCTED DURING PRODUCTION. A 2-YEAR REVIEW OF VYGON USA'S COMPLAINTS DATA FROM JANUARY 1, 2022, TO AUGUST 30, 2024, INDICATES THAT THIS IS THE FIRST COMPLAINT RECORDED FOR LOT 23H006D. CORRECTIVE ACTION: AS THE CATHETER WORKED WELL FOR 22 DAYS BEFORE THE LEAKAGE OCCURRED, WE DO NOT BELIEVE THIS DEFECT IS MANUFACTURING RELATED. ANY MANUFACTURING PROBLEMS THAT WOULD LEAD TO A LEAK WOULD BE DETECTED BY THE USER WHEN INITIALLY FLUSHING THE CATHETER. THEREFORE, NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT AT THIS TIME.

    Description of Event or Problem · 0

    CALLED TO BEDSIDE FOR LEAKING CATHETER. LEAKING AT NARROW PART OF HUB.

    Description of Event or Problem · 0

    CALLED TO BEDSIDE FOR LEAKING CATHETER. LEAKING AT NARROW PART OF HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313372 PREMICATH INTRAVASCULAR CATHETER LJS VYGON USA 1261.203A 23H006D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female