BEUDAMED
    FDA Adverse Event Summary report: N

    VENOSCOPE II

    MDR report key: 600740 · Received May 4, 2005

    Report

    Report Number
    600740
    Date Received
    May 4, 2005
    Date of Event
    April 28, 2005
    Report Date
    May 4, 2005
    Manufacturer
    VENOSCOPE
    Product Code
    HJN
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    A VENOSCOPE II NEONATAL TRANSILLUMINATOR WAS USED TO IDENTIFY A VEIN FOR A PERIPHERAL IV INSERTION. AFTER INSERTION OF THE IV IN THE RIGHT FOREARM, A BURN BLISTER WAS NOTED ON THE POSTERIOR ASPECT OF THE RIGHT FOREARM BELOW THE ELBOW. BIOMEDICAL ENGINEERING ANALYSIS REVEALED THAT 2 UNITS THAT WERE RECENTLY PURCHASED (THE ONLY ONES OF THIS TYPE IN THE FACILITY) HAD LED'S (LIGHT EMITTING DIODES) AT THE END OF THE TRANSILLUMINATOR THAT GET WARM. WITH MINIMAL PRESSURE, THEY GET HOT ENOUGH TO CAUSE BURNING IN INFANTS. THE MANUFACTURER OWNER WAS CONTACTED AND ADMITS THAT A 'BATCH' OF THESE HAVE REVERSED WIRING. HOWEVER, NO MARKINGS OR SERIAL OR LOT NUMBERS COULD BE FOUND ON THE DEVICE THAT WOULD IDENTIFY WHICH DEVICES ARE DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOSCOPE II NEONATAL TRANSILLUMINATOR HJN VENOSCOPE NT01 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO