BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 8286119 · Received January 29, 2019

    Report

    Report Number
    2245270-2019-00009
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    November 24, 2018
    Report Date
    April 18, 2019
    Manufacturer
    VYGON MFG
    Product Code
    LJS
    PMA / PMN Number
    K052475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS FORWARDED TO THE MANUFACTURING SITE, (B)(4) FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: WE RECEIVED THE Y-PIECE AND THE SEPARATED STYLET AS SAMPLES. THE STYLET SHOWS A KINK AND IS SLIGHTLY WAVY - APPROX. 10,5 CM FROM DISTAL END. IT APPEARS THAT THE USER HAD STYLET REMOVAL ISSUES. THE PROXIMAL END OF THE STYLET IS TWISTED; THIS IS LIKELY CAUSED BY PULLING HARD CAUSING THE KINK AND WAVINESS. IT IS IMPORTANT TO FOLLOWING FROM THE PRODUCT'S IFU: "IF DIFFICULTY IS EXPERIENCED REMOVING THE STYLET STOP, LET VEIN REST FOR A MINUTE AND TRY REMOVAL AGAIN VERY SLOWLY. GENTLE FLUSHING OF THE CATHETER WITH SALINE MAY ASSIST IN STYLET REMOVAL." NO DEVIATIONS OF THE BATCH HISTORY RECORDS DETECTED. EACH CATHETER IS FLOW AND LEAK TESTED, AND A 100% VISUAL TEST IS CARRIED OUT. THE TENSILE FORCE OF Y-PIECE AND STYLET IS RANDOMLY CHECKED. FOR THE INVOLVED BATCHES THE TENSILE FORCE WAS BETWEEN 5,52 N AND 7,58 N AND THEREFORE WITHIN THE SPECIFICATION. THIS IS THE 7TH COMPLAINT RECEIVED FOR BATCH 8023296; HOWEVER, THE LOT SIZE WAS 1,250 PIECES; THEREFORE, A 0.56% COMPLAINT RATE. THERE HAVE BEEN TWO OTHER COMPLAINTS FOR PRODUCT CODE 4G07125223 REGARDING SEPARATED STYLETS. 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. ADDITIONALLY, VYGON HAS NOTED THAT THESE TYPES OF COMPLAINTS APPEAR TO BE ISOLATED TO CANADA AND VYGON IS ATTEMPTING TO WORK WITH THE HOSPITAL TO HAVE CLINICAL MEET WITH, SIT IN AND SHADOW.

    Description of Event or Problem · 0

    STYLET INSERTED WITH PICC. STYLET BROKE FROM DEVICE.

    Additional Manufacturer Narrative · 1

    THE FAILED SAMPLE HAS BEEN RETURNED TO VYGON FOR DEVICE 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

    STYLET INSERTED WITH PICC. STYLET BROKE FROM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77104 NUTRILINE LONG-TERM INTRAVASCULAR CATHETER LJS VYGON MFG 1252.230G 18A001D

    Patients

    Seq Age Sex Outcome Treatment
    1