BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE PICC

    MDR report key: 4801884 · Received May 26, 2015

    Report

    Report Number
    2245270-2015-00049
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    April 21, 2015
    Report Date
    May 26, 2015
    Manufacturer
    VYGON GMBH
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYGON HAS BEEN THOROUGHLY INVESTIGATING ALL COMPLAINTS RELATED TO LEAKAGE OF NUTRILINE CATHETERS. THIS INCLUDES, BUT IS NOT LIMITED TO INVESTIGATION OF THE RAW MATERIAL AND RAW MATERIAL DEVELOPMENT, THE MANUFACTURING PROCESS OF THE CATHETER, AND STERILIZATION. THERE HAS BEEN NO CHANGE TO ANY MATERIAL OR PROCESS. VYGON HAS CONDUCTED A SERIES OF TESTS AGAINST THE NUTRILINE PRODUCT INCLUDING KNOWN SKIN PREPARATION AGENTS AND CLEANING SOLUTIONS. AS INDICATED IN THE TABLE BELOW, THERE IS A RECOGNIZED REDUCTION IN TENSILE STRENGTH WHEN AGENTS CONTAINING ALCOHOL COME INTO CONTACT WITH THE NUTRILINE MATERIAL. IT IS UNDETERMINED AT THIS TIME IF THE PRODUCT IS NON- CONFORMING OR IF THE CAUSE IS THE RESULT OF CLINICAL USE. AS NOTED IN THE IFU, THE USE OF ORGANIC SOLVENTS CAN CAUSE THE SYSTEM TO LEAK, AND SHOULD NOT BE USED WITH THE CATHETER.

    Additional Manufacturer Narrative · 1

    THERE WAS AN ADDITIONAL OCCURRENCE OF THIS CAUSE OF CONDITION IN THIS PRODUCT LOT. PLEASE REFERENCE THE FOLLOWING MDR FOR ADDITIONAL INFO: MDR#2245270-2015-00048. THE DEVICE WAS RETURNED TO VYGON FOR EVALUATION AND 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

    CATHETER PLACED IN LEG USING A TUNNEL TECHNIQUE, AFTER SOME THERAPY LINE WAS FOUND TO BE LEAKING. THE PICC WAS THEN REMOVED. NO ISSUES WERE REPORTED WITH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339991 NUTRILINE PICC LONG TERM INTRAVASCULAR CATHETER LJS VYGON GMBH 1252.030G 160914GC

    Patients

    Seq Age Sex Outcome Treatment
    1