BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREMICATH

    MDR report key: 265309 · Received February 29, 2000

    Report

    Report Number
    2245270-2000-00004
    Event Type
    Death
    Date Received
    February 29, 2000
    Date of Event
    December 15, 1999
    Manufacturer
    VYGON GMBH & CO KG
    Product Code
    DQO
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    12/09/1999 DEVICE WAS PLACED FOR THE INFUSION OF HYPERALIMENTATION AND INTRALIPIDS. ON 12/15/1999 INFANT BECAUSE BRADYCARDIAC AND WAS NOTED TO HAVE DESATURATED AND HAVE A BLUISH DISCOLORATION OF THE ABDOMEN. THE INFANT EXPIRED SHORTLY AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMICATH PERIPHERALLY INSERTED CENTRAL CATHETER DQO VYGON GMBH & CO KG 1261.20K UNK

    Patients

    Seq Age Sex Outcome Treatment
    1