BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMBI SET

    MDR report key: 978123 · Received August 3, 2007

    Report

    Report Number
    8030665-2007-00061
    Event Type
    Death
    Date Received
    August 3, 2007
    Report Date
    August 3, 2007
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKJ
    PMA / PMN Number
    k962081
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS THE BELIEF BY FMC NA THAT THIS STATEMENT "PATIENT KNOWN TO PLAY THE CATHETER TUBING" MADE BY THE USER FACILITY HAS IDENTIFIED THAT POSSIBLY THE PT BEHAVIOR MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. ALSO, IT IS POSSIBLE THAT THE CONNECTION BECAME LOOSE BECAUSE THE FACILITY REPORTED THAT THERE WAS NOTHING USED TO SECURE THE CONNECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBI SET FKJ REYNOSA MANUFACTURING NA

    Patients

    Seq Age Sex Outcome Treatment
    1