BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UAC

    MDR report key: 2161221 · Received July 1, 2011

    Report

    Report Number
    2161221
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    May 26, 2011
    Report Date
    July 1, 2011
    Manufacturer
    UTAH MEDICAL
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN ATTEMPTED TO GET AN ARTERIAL BLOOD GAS (ABG) FROM UAC LINE THAT WAS INSERTED EARLIER THAT DAY. ONLY BUBBLES WERE NOTED COMING INTO WASTE SYRINGE. RN THEN NOTED BLOOD ON STERILE 4X4 AND BLOOD COMING FROM HUB/CATHETER SITE. A SMALL TEAR OR HOLE WAS NOTED. UAC LINE CLAMPED WITH ORANGE TEAM NNP NOTIFIED. ORDER WAS GIVEN TO DISCONTINUE UAC FROM NNP. UAC DISCONTINUED WITH CATHETER INTACT. THIS IS THE SAME PRODUCT THAT THE HOSPITAL HAS HAD OTHER ISSUES WITH. THE BREAK IN THE CATHETER IS AT SAME PLACE. RN'S HAVE NO KNOWLEDGE OF CATHETER BEING PINCHED OR KINKED. THERE WAS NO BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UAC CATHETER, UMBILICAL ARTERY FOS UTAH MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO