BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILI-CATH

    MDR report key: 5029231 · Received August 20, 2015

    Report

    Report Number
    MW5055716
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 20, 2015
    Manufacturer
    UTAH MEDICAL PRODUCTS
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    (B)(6) MEDICAL PRODUCTS UMBILI-CATH DUAL LUMEN SILICONE CATHETER 5 FRENCH, HUB DISCONNECTED FROM CATHETER ITSELF, COULD HAVE LED TO ACCIDENTAL EXSANGUINATION. ITEM REF # (B)(4), LOT # 1141566, EXP. DATE 07/2019. DIAGNOSIS OR REASON FOR USE: CARDIOPULMONARY MONITORING OF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551942 UMBILI-CATH UMBILI-CATH FOS UTAH MEDICAL PRODUCTS 5 FRENCH 1141566

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Other