BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 11785712 · Received May 6, 2021

    Report

    Report Number
    2245270-2021-00075
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 15, 2021
    Report Date
    June 29, 2021
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K052475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MALFUNCTION WAS ALSO SENT TO FDA VIA MEDWATCH REPORT NUMBER (B)(4). THE COMPLAINT WAS FORWARDED TO OUR PARENT COMPANY IN GERMANY FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: THIS COMPLAINT COULD NOT BE CLASSIFIED AS WE DID NOT RECEIVE A SAMPLE FOR EVALUATION AND NO FURTHER DETAILED INFORMATION, SUCH AS THE DURATION, DISINFECTANT USED, MEDICATION AND SYRINGE SIZE USED. FROM PREVIOUS COMPLAINTS WE LEARN OF VARIOUS POSSIBLE CAUSES OF THIS FAILURE. IN MOST CASES, THE CATHETERS HAD THEN BEEN IN PLACE FOR A LONGER PERIOD AND FIBRIN DEPOSITS HAD FORMED ALONG THE CATHETER TUBE, MAKING IT DIFFICULT OR IMPOSSIBLE TO REMOVE THE CATHETER. FIBRIN FORMATION CAN OCCUR IN VERY RARE OCCASIONS AND CAN HAVE VARIOUS REASONS: ALLERGIC PATIENT REACTION TO LATEX IF LATEX GLOVES (EVEN UNPOWDERED ONES) ARE WORN DURING INSERTION. ALLERGIC PATIENT REACTION TO PUR (IN VERY RARE OCCASIONS). POOR/UNFAVOURABLE CATHETER PLACEMENT, SO THAT THE INTIMA IS IRRITATED BY CATHETER MOVEMENTS. THE PRESENCE OF HOSPITAL BACTERIA (ON THE CATHETER TIP). IN CASE OF RECURRENCE (BEFORE DECONTAMINATION OF THE SAMPLE) THE CATHETER TIP SHOULD BE EXAMINED IN THE LABORATORY BATCHES HISTORY RECORDS WERE REVIEWED, AND NO DEVIATIONS WERE FOUND. EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION. THE TENSILE FORCE AND DIMENSIONS OF CATHETER COMPONENTS ARE RANDOMLY CHECKED FOLLOWED BY AN INCOMING GOODS INSPECTION AND TWO 100% VISUAL TESTS AFTER PACKAGING IS CARRIED OUT. THIS IS THE FIRST COMPLAINT FOR THE INVOLVED BATCHES 8084421 AND 8093927 AND THE VERY FIRST COMPLAINT REGARDING A SNAPPED CATHETER ON CODE 4G07125223 DURING REMOVAL PROCESS. NO FURTHER CORRECTIVE ACTION INITIATED BY QUALITY MANAGEMENT AS DUE TO THE MISSING SAMPLE, NO ROOT CAUSE ANALYSIS CAN BE MADE. CORRECTIVE ACTION: WITHOUT THE SAMPLE AND FURTHER INFORMATION, THE CAUSE OF THIS ISSUE COULD NOT BE DETERMINED. THEREFORE, NO CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME. THIS FAILURE WILL BE MONITORED FOR FUTURE ACTIONS.

    Description of Event or Problem · 0

    DURING IMAGE GUIDED REMOVAL, THE DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE LOCATED IN THE RIGHT SAPHENOUS VEIN FRACTURED AND 4.5CM OF THE CATHETER WAS RETAINED IN THE PATIENT. NO HARM TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THIS MALFUNCTION WAS ALSO SENT TO FDA VIA MEDWATCH REPORT NUMBER (B)(4). THE COMPLAINT INVESTIGATION IS CURRENTING IN PROCESS, AND THE RESULTS WILL BE COMMUNICATED TO FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.

    Description of Event or Problem · 1

    DURING IMAGE GUIDED REMOVAL, THE DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE LOCATED IN THE RIGHT SAPHENOUS VEIN FRACTURED AND 4.5CM OF THE CATHETER WAS RETAINED IN THE PATIENT. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681049 NUTRILINE LONG-TERM-INTRAVASCULAR CATHETER LJS VYGON USA 1252.230G 20C016D

    Patients

    Seq Age Sex Outcome Treatment
    1