BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN PICC

    MDR report key: 2682416 · Received July 23, 2012

    Report

    Report Number
    MW5026381
    Event Type
    Malfunction
    Date Received
    July 23, 2012
    Date of Event
    July 6, 2012
    Report Date
    July 23, 2012
    Manufacturer
    MARIAN MEDICAL, INC
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PICC LINE PLACED AND SECURED. HUB BROKE AND DISCONNECTED FROM CATHETER LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN PICC NEONATAL SILICONE PICC CATHETER LJS MARIAN MEDICAL, INC PICC-2 11346

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA