BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER, UMBILICAL ARTERY

    MDR report key: 10875842 · Received November 20, 2020

    Report

    Report Number
    10875842
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Date of Event
    June 3, 2020
    Report Date
    October 9, 2020
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UAC INSERTED BY NEONATAL NURSE PRACTITIONER (NNP) AT 1730. WHEN HOOKING UP UAC FLUIDS NOTICED THAT LINE WAS LEAKING JUST BELOW THE HUB WHERE FLUIDS ARE CONNECTED. NNP NOTIFIED AND LINE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341802 CATHETER, UMBILICAL ARTERY FOS 1924700105

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA