BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICATH 1FR PICC WITH STYLET

    MDR report key: 2945225 · Received January 31, 2013

    Report

    Report Number
    2245270-2013-00007
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 31, 2013
    Manufacturer
    VYGON GMBH
    Product Code
    LJS
    PMA / PMN Number
    K041468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 MFR) FOR EVAL AND INVESTIGATION. THE RESULTS OF THIS INVESTIGATION WILL BE FORWARDED IN A F/U MDR WITHIN 30 DAYS OF ITS CONCLUSION.

    Description of Event or Problem · 1

    A PICC LINE SNAPPED IN HALF WHEN BEING REPOSITIONED. IT DID NOT SEEM TO BE LEAKING AT ALL WHEN FLUSHED. THE GUIDEWIRE IN THE PICC WAS HARD TO PULL OUT ONCE IN PLACE. THE NURSE WAS NOT SURE IF THE GUIDEWIRE MADE THE LINE WEAKENED, BUT IT SNAPPED WHEN AN EASY TO REMOVE STERI-STRIP WAS TAKEN OFF. THE PT WAS NOT HARMED, AND THE NURSE WAS ABLE TO PUT ANOTHER CATHETER IN THE OTHER ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42788 PREMICATH 1FR PICC WITH STYLET NEONATAL PICC LJS VYGON GMBH 1261.203G

    Patients

    Seq Age Sex Outcome Treatment
    1 31 DA