BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 10656367 · Received October 9, 2020

    Report

    Report Number
    2245270-2020-00099
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    September 15, 2020
    Report Date
    November 13, 2020
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS FORWARDED TO OUR PARENT COMPANY IN GERMANY FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: WE RECEIVED ONE CATHETER AS A SAMPLE INTO TWO PIECES. MICROSCOPIC EXAMINATION CONFIRMED THAT THE CATHETER HAD BEEN CUT WITH A SHARP INSTRUMENT JUST PROXIMAL THE 30 CM MARKING. THIS WAS EVIDENT BY THE VISIBLE GROOVES. FURTHERMORE, THE CATHETER TUBE HAD SNAPPED AT THE 15 CM MARKING. THE ROUGH SURFACE PROVIDED VISUAL CONFIRMATION OF A TENSILE FRACTURE. THE DISTAL PART OF THE CATHETER TUBE WAS MISSING. SEVERE OCCLUSIONS WERE VISIBLE INSIDE THE CATHETER TUBE. 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 FIRST COMPLAINT FOR THE INVOLVED BATCHES 8070801, 8078460 AND 8080362 AND THE FIFTH REGARDING A LEAKING CATHETER TUBE ON CODE 4G07125203 WITHIN THE LAST THREE YEARS. NO FURTHER CORRECTIVE ACTION INITIATED BY QUALITY MANAGEMENT AS THE CATHETER WORKED WELL FOR 13 DAYS AND THERE ARE NO INDICATIONS OF A MANUFACTURING FAULT. CORRECTIVE ACTION: BASED ON THE INVESTIGATION, THE REPORTED CONDITION WAS NOT RELATED TO MANUFACTURING FAULT. THEREFORE, NO FURTHER CORRECTIVE WILL BE INITIATED AT THIS TIME. THIS FAILURE WILL BE MONITORED FOR FUTURE ACTIONS.

    Description of Event or Problem · 0

    LEAKING AT THE WINGS DURING PICC DRESSING CHANGE WAS REPORTED. REPAIR WAS ATTEMPTED, NOT SUCCESSFUL. WHEN CHECKED, FLUIDS CAME OUT THROUGH THE END OF THE SHORTENED CATHETER.

    Additional Manufacturer Narrative · 1

    THE FAILED SAMPLE WILL BE RETURNED TO VYGON FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION.

    Description of Event or Problem · 1

    LEAKING AT THE WINGS DURING PICC DRESSING CHANGE WAS REPORTED. REPAIR WAS ATTEMPTED, NOT SUCCESSFUL. WHEN CHECKED, FLUIDS CAME OUT THROUGH THE END OF THE SHORTENED CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120049 NUTRILINE LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA 1252.030G 19J010D OR 19H004D

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR