BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE 2D PICC

    MDR report key: 3032754 · Received March 29, 2013

    Report

    Report Number
    2245270-2013-00016
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    VYGON GMBH
    Product Code
    LJS
    PMA / PMN Number
    K052475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH, THE FAILED SAMPLE WAS NOT RETURNED TO VYGON US, THE COMPLAINT HAS BEEN FORWARDED TO VYGON (B)(4) (THE MANUFACTURER) FOR EVALUATION AND INVESTIGATION. THE RESULTS OF THIS INVESTIGATION WILL BE FORWARDED IN A FOLLOW-UP MDR WITHIN 30 OF ITS CONCLUSION.

    Description of Event or Problem · 1

    A NUTRILINE PICC WAS PLACED AND ENCOUNTER A PRODUCT PROBLEM FIVE DAYS LATER. WHILE THE TEGADERM WAS BEING REMOVED DURING A DRESSING CHANGE, THE CATHETER SNAPPED AT THE PLACE WHERE IT CONNECTS TO THE WINGED HUB. THERE WAS NO UNUSUAL FORCE WITH REMOVING THE TEGADERM. IT WAS THEN NOTED THAT ABOUT 1CM ABOVE THE INSERTION SITE THERE WAS A FIBROUS 2CM IN LENGTH AREA FOLLOWING THE PATH OF THE CATHETER. THE CATHETER WOULD NOT PULL BACK AND IT TOOK OVER 30 MINUTES TO REMOVE THE CATHETER. IT WOULD PULL BACK IN SMALL AMOUNTS WHILE LEG WAS BEING MASSAGED. THE DOCTOR HAS TO ASSIST WITH THE REMOVAL OF THIS CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129863 NUTRILINE 2D PICC NEONATAL PICC LJS VYGON GMBH 1252.30G 141112GA

    Patients

    Seq Age Sex Outcome Treatment
    1