BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE UMBILICAL CATHETER

    MDR report key: 16453419 · Received February 27, 2023

    Report

    Report Number
    MW5115278
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    October 9, 2022
    Report Date
    February 2, 2023
    Manufacturer
    FOOTPRINT MEDICAL INC.
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A 3.5 UAC PLACED IN INFANT XRAY AND OBTAINED CATH NOT IN POSITION. GENTLE PRESSURE APPLIED PER NNP TO PULL BACK INTO POSITION AND CATH SNAPPED. PRESSURE HELD AND REMAINING PIECE REMOVED INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946879 SILICONE UMBILICAL CATHETER CATHETER, UMBILICAL ARTERY FOS FOOTPRINT MEDICAL INC. S1UVC-3540 201467

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male