BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE 2 FR PICC

    MDR report key: 4180260 · Received October 15, 2014

    Report

    Report Number
    2245270-2014-00087
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 2, 2014
    Report Date
    October 14, 2014
    Manufacturer
    VYGON GMBH
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE TWO ADDITIONAL OCCURRENCES OF SIMILAR CAUSES OF CONDITION IN THIS PRODUCT. PLEASE REFERENCE THE FOLLOWING MDRS FOR ADDITIONAL INFORMATION: MDR: 2245270-2014-00085, MDR: 2245270-2014-00086. ALTHOUGH THE MALFUNCTIONING DEVICES WERE NOT RETURNED, THE DETAILS OF THE COMPLAINT HAVE BEEN FORWARDED TO THE DEVICE MANUFACTURER FOR 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

    WHEN REMOVING THE TEGADERM DRESSING THE NURSE NOTED A COMPLETE BREAK FROM THE POLYURETHANE TO WING CONNECTION OF CATHETER. TWO SIMILAR OCCURRENCES TOOK PLACE WITH THIS PRODUCT IN THIS UNIT. IN ALL CASES THERE WERE NO HARMFUL OR ADVERSE EFFECTS. THE PATIENTS NEEDED TO BE REACCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653740 NUTRILINE 2 FR PICC LONG TERM INTRAVASCULAR CATHETER LJS VYGON GMBH 1252.31G 220114GA

    Patients

    Seq Age Sex Outcome Treatment
    1