BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILI-CATH SINGLE LUMEN SILICONE UMBILICAL

    MDR report key: 1822032 · Received July 26, 2010

    Report

    Report Number
    1718873-2010-00011
    Event Type
    Malfunction
    Date Received
    July 26, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 14, 2010
    Manufacturer
    UTAH MEDICAL PRODUCTS
    Product Code
    FOS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UTMD IS FILING THIS REPORT BECAUSE THE HOSPITAL MEDWATCH REPORT RECEIVED BY UTMD INDICATED AN ADVERSE EVENT WHICH REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THIS CONTRADICTS THE INFO OBTAINED BY UTMD AFTER IT RECEIVED A REPORT OF THE EVENT ON (B)(6) 2010 WHICH INDICATED THE CATHETER WAS REMOVED FROM THE PATIENT WITH NO PATIENT IMPACT, AND NO BLOOD LOSS. UTMD CONFIRMED THE CATHETER BROKE AT THE HUB (PROXIMAL END), AWAY FROM THE PATIENT. EVAL: THE PRODUCT HAS NOT BEEN RETURNED TO UTMD FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    UMBILICAL ARTERIAL CATHETER BROKE AT THE DISTAL END OF THE CATHETER, NURSE ON SITE WHEN EVENT OCCURRED AND CLAMPED LINE TO PREVENT BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UMBILI-CATH SINGLE LUMEN SILICONE UMBILICAL UMBILICAL ARTERIAL CATHETER FOS UTAH MEDICAL PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention