BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 8378702 · Received February 28, 2019

    Report

    Report Number
    2245270-2019-00015
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Date of Event
    February 16, 2019
    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 MANUFACTURER, (B)(4), FOR EVALUATION. THE FOLLOWING IS A SUMMARY OF THEIR EVALUATION: THE EXAMINATION OF THE FAULTY SAMPLE SHOWED THAT THE CATHETER WAS LEAKING FROM THE GREEN LUMEN APPROX. 2,1 CM DISTAL FROM THE WING; THE ORANGE LINE DID NOT PRESENT LEAKING. THE CATHETER TUBE WAS SHORTENED AT THE END MARKING (APPROX. 3,5 CM DISTAL FROM THE WING). WE DID NOT RECEIVE THE DISTAL PART OF THE CATHETER TUBE. A MICROSCOPIC EXAMINATION SHOWED SIGNS OF CATHETER DAMAGE BY THE STYLET. THE GREEN LINE IS USED FOR THE STYLET; THUS, IT IS SUSPECTED THAT THE USER HAD STYLET REMOVAL ISSUES CAUSING THE STYLET TO CUT INTO THE CATHETER'S WALL (SEE PICTURES BELOW). BASED ON THIS INVESTIGATION, A MANUFACTURING DEFECT COULD NOT BE DETERMINED. WE BELIEVE THIS COULD BE DUE TO DEVICE USE. PLEASE NOTE THE FOLLOWING AS IT RELATES TO AVOIDING KINKING OF THE STYLET AND STYLET WITHDRAWAL: · "IF DIFFICULTY IS EXPERIENCED 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. THIS IS THE 7TH COMPLAINT RECEIVED FOR BATCH 8023296; HOWEVER, THIS BATCH SIZE WAS 1,250 PIECES; THEREFORE, A 0.56% COMPLAINT RATE. OVER THE PAST THREE YEARS, THERE HAVE BEEN TEN OTHER COMPLAINTS FOR PRODUCT CODE 4G07125223 REGARDING LEAKING CATHETERS; HOWEVER, NONE WERE DETERMINED TO BE MANUFACTURING RELATED. CORRECTIVE ACTION: 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

    LEAKING NOTED AT THE TIME OF INSERTION

    Additional Manufacturer Narrative · 1

    TWO OCCURRENCES OF THIS MALFUNCTION WERE REPORTED TO VYGON, THE DETAILS OF THE OTHER CAN BE FOUND IN MDR 2245270-2019-00014. ONE DEVICE WAS RETURNED TO VYGON FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE REPORTED TO FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.

    Description of Event or Problem · 1

    LEAKING NOTED AT THE TIME OF INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173561 NUTRILINE LONG-TERM INTRAVASCULAR CATHETER LJS VYGON MFG 1252.230G 18H006D

    Patients

    Seq Age Sex Outcome Treatment
    1