BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILI-CATH

    MDR report key: 12142246 · Received July 9, 2021

    Report

    Report Number
    12142246
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    April 2, 2021
    Report Date
    June 24, 2021
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UAC (UMBILICAL ARTERY CATHETER) STOPCOCK FOUND CRACKED AFTER NOTING AIR IN THE LINE. THIS IS A DISPOSABLE LINE WITH A CRACK CAUSING AIR TO GET INTO UMBILICAL LINE. AIR WAS SEEN AND REMOVED THE STAFF. NO AIR GOT THROUGH THE LINE TO THE BABY. STOPCOCK CHANGED AND CRACKED ONE REMOVED. CHECKED PAR CARTS AND CENTRAL STOCK, DID NOT FIND ANY AFFECTED LOT# 1202974.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037999 UMBILI-CATH CATHETER, UMBILICAL ARTERY FOS UTAH MEDICAL PRODUCTS, INC. SINGLE-LUMEN SILICONE 1202974

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA