BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILI-CATH

    MDR report key: 7670835 · Received July 6, 2018

    Report

    Report Number
    MW5078288
    Event Type
    Malfunction
    Date Received
    July 6, 2018
    Date of Event
    June 30, 2018
    Report Date
    July 3, 2018
    Manufacturer
    UTAH MEDICAL PRODUCTS
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DUAL LUMEN UVC CATHETER "SNAPPED" (BROKE OFF) RIGHT BELOW THE "Y" JUNCTURE. NURSE CLAMPED THE CATHETER WITH HEMOSTATS PREVENTING BLOOD LOSS. DR/NNP NOTIFIED, CATHETER REMOVED. UNABLE TO OBTAIN PERIPHERAL IV ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510558 UMBILI-CATH CATHETER, UMBILICAL ARTERY FOS UTAH MEDICAL PRODUCTS 1162154

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA