BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILI-CATH

    MDR report key: 12142245 · Received July 9, 2021

    Report

    Report Number
    12142245
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    May 19, 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

    WHILE NURSE WAS CARRYING OUT ORDER TO PULL BACK UMBILICAL ARTERY CATHETER, CATHETER SNAPPED IN HALF. NURSE VERY QUICKLY GRABBED LINE AND NOTIFIED PHYSICIAN. PHYSICIAN WAS ABLE TO TAKE THE REST OF THE LINE OUT. INFANT DID LOSE ABOUT 5 ML OF BLOOD DURING THE PROCEDURE. UMBILI-CATH-SINGLE LUMEN SILICONE UMBILICAL CATHETER 3.5 FRENCH; LOT # 1202974.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037994 UMBILI-CATH CATHETER, UMBILICAL ARTERY FOS UTAH MEDICAL PRODUCTS, INC. SINGLE-LUMEN SILICONE 1202974

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA