BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VEINLITE NEO

    MDR report key: 17253932 · Received July 5, 2023

    Report

    Report Number
    17253932
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    May 29, 2023
    Report Date
    June 19, 2023
    Manufacturer
    TRANSLITE LLC
    Product Code
    KYT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PROVIDER WAS ATTEMPTING ARTERIAL STICK IN THE LEFT RADIAL ARTERY WITH THE ASSISTANCE OF RN. PROVIDER USED A SMALL LIGHT, TO VISUALIZE ARTERY, WHILE ATTEMPTING ART STICK. THE LIGHT WAS HELD AGAINST THE DORSAL ASPECT OF THE PT'S LEFT WRIST. THE LIGHT WAS REMOVED AND REPLACED SEVERAL TIMES THROUGHOUT THE PROCEDURE BECAUSE IT KEPT TURNING OFF. AFTER PROCEDURE WAS COMPLETED, RN SAW THAT THE PATIENT HAD A LARGE ROUND BURN TO THE DORSAL ASPECT OF THEIR WRIST. THE BURNED AREA WAS WHITE AND RAISED WITH A SMALL SEMICIRCULAR ERYTHEMIC BLISTER. PROVIDER WAS NOTIFIED AND CAME TO ASSESS THE BURN SITE. MANUFACTURER RESPONSE FOR VEIN FINDER, VEINLITE NEO (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932141 VEINLITE NEO LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED KYT TRANSLITE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Male Other