BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UTAH MEDICAL UMBILI-CATH

    MDR report key: 5001512 · Received August 10, 2015

    Report

    Report Number
    MW5055359
    Event Type
    Injury
    Date Received
    August 10, 2015
    Date of Event
    July 26, 2015
    Report Date
    August 4, 2015
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UVC LINE IN FOR 14 DAYS PRIOR TO NOTING THAT FLUID WAS LEAKING OUT OF 23 GAUGE PORT. D15W WAS INFUSING VIA THE 20 GAUGE PORT AND APPEARED TO BE LEAKING AT THE Y-HUB. WHEN THE LINE WAS FLUSHED, THE FLUID WAS SEEN LEAKING FROM THE 23 GAUGE PORT. THE UVC WAS REMOVED AND PIV WAS INSERTED. MANUFACTURER: PLEASE NOTE THAT WE DO NOT SENT PRODUCTS TO THE MANUFACTURER, BUT YOU MAY ARRANGE FOR PICK-UP BY CALLING MY NUMBER BELOW. PACKAGING NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522714 UTAH MEDICAL UMBILI-CATH UMBILICAL VENOUS CATHETER - DUAL LUMEN SILICONE 3.5 FR. FOS UTAH MEDICAL PRODUCTS, INC. UNK 1141880??

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DA Required Intervention