BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE TWINFLO

    MDR report key: 19493385 · Received June 8, 2024

    Report

    Report Number
    2245270-2024-00051
    Event Type
    Malfunction
    Date Received
    June 8, 2024
    Report Date
    July 29, 2024
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K052475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE RECEIVED THE CATHETER WITH A NEEDLE-FREE CONNECTOR AS A FAULTY SAMPLE. BOTH LUMENS WERE FLUSHABLE WITH A 10 ML SYRINGE. DURING MICROSCOPIC EXAMINATION, A LEAKAGE WAS DETECTED JUST PROXIMAL TO THE 29.5 CM MARKING. A LITTLE LONGITUDINAL CUT WAS VISIBLE, PROBABLY CAUSED BY A SHARP INSTRUMENT. OBVIOUSLY, THIS CUT CAUSED THE LEAKAGE. FURTHERMORE, WE FOUND A HOLE AT THE JUNCTION OF THE CATHETER WITH THE FIXATION WING. THE CATHETER TUBE WAS PARTLY TORN OUT OF THE FIXATION WING. THE FRACTURE PLANE SHOWED A ROUGH AND UNEVEN SURFACE, WHICH IS A TYPICAL SIGN FOR A TENSILE FRACTURE DUE TO A HIGH TENSILE LOAD. THERE ARE VARIOUS EVENTS THAT CAN LEAD TO A LEAKING CATHETER: 1.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. 2. MECHANICAL DAMAGE BY A SHARP INSTRUMENT (FOR EXAMPLE SCISSORS, TOOTHED FORCEPS, OR SCALPEL) DURING DRESSING CHANGE. 3. ALCOHOL-BASED DISINFECTANT- CONCERNING THIS, THERE ARE SOME WARNINGS IN THE 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." A REVIEW OF THE BATCH HISTORY RECORDS FOR BATCHES 8212769,8210779 & 8150601 WAS PERFORMED, AND NO DEVIATIONS WERE FOUND. THE BATCHES COMPLIED WITH ITS SPECIFICATIONS AND WERE RELEASED. EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION. THE TENSILE FORCE AND DIMENSIONS OF THE CATHETER/SET COMPONENTS ARE RANDOMLY CHECKED. INCOMING GOODS INSPECTIONS AND TWO 100% VISUAL TESTS AFTER PACKAGING ARE CONDUCTED DURING PRODUCTION. A TWO-YEAR REVIEW OF COMPLAINTS DATA BY VYGON USA INDICATES THAT THERE WERE EIGHT REPORTED COMPLAINTS FOR PRODUCT 1252.232G. ALL EIGHT COMPLAINTS ORIGINATED FROM THIS FACILITY. CORRECTIVE ACTION: BASED ON THE INVESTIGATION, THERE ARE NO INDICATIONS OF A MANUFACTURING FAULT. THEREFORE, NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT AT THIS TIME.

    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.

    Description of Event or Problem · 0

    DUAL LUMEN PICC PLACED (B)(6) 2024. THE LEAKING PICC REMOVED FROM PATIENT.

    Description of Event or Problem · 0

    DUAL LUMEN PICC PLACED ON (B)(6) 2024. THE LEAKING PICC REMOVED FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319876 NUTRILINE TWINFLO INTRAVASCULAR CATHETER LJS VYGON USA 1252.232G 23H002D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown