BEUDAMED
    FDA Adverse Event Death Summary report: N

    VYGON PREMI-CATH NEONATAL FLEXANE CATHETER KIT

    MDR report key: 265300 · Received February 29, 2000

    Report

    Report Number
    265300
    Event Type
    Death
    Date Received
    February 29, 2000
    Date of Event
    December 15, 1999
    Report Date
    February 14, 2000
    Manufacturer
    VYGON CORP.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 12/09/1999, THIS PREMATURE INFANT HAD A PICC LINE PLACED FOR INFUSION OF HYPERALIMENTATION AND INTRALIPIDS. THE PT'S CLINICAL COURSE WAS UNEVENTFUL UNTIL 0320 ON 12/15/1999 WHEN INFANT WAS NOTED TO DESATURATE AND BECAME BRADYCARDIC. INFANT WAS NOTED TO HAVE A BLUISH DISCOLORATION OF THE ABDOMEN. AT 0324 INFANT BECAME PULSELESS. RESUSCITATION EFFORTS WERE UNSUCCESSFUL AND THE INFANT WAS PRONOUNCED DEAD AT 0455.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VYGON PREMI-CATH NEONATAL FLEXANE CATHETER KIT PICC LINE DQO VYGON CORP. 27G CATHETER & 24G INTRODUCING UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 11 DAY Death 1. 12/4/1999 CPAP,| 3. 12/9/1999-12/14/1999 CONVENTIONAL VENTILATION.| 2. 12/5/1999-12/9/1999 HIGH FREQUENCY VENTILATOR,