BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GESCO

    MDR report key: 4124574 · Received September 19, 2014

    Report

    Report Number
    4124574
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    May 2, 2014
    Report Date
    August 22, 2014
    Manufacturer
    UTAH MEDICAL PRODUCTS
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    NICU RN REPORTED THAT THE STOPCOCK TO (B)(6) GESCO SYSTEM (LOT #1130033) HAD "BROKEN OFF." AT THE BEDSIDE IT WAS SEEN THAT THE ENTIRE STOPCOCK HAD COME OFF THE SYSTEM. MD NOTIFIED, PERITONEAL DIALYSATE CULTURES DRAWN, AND A NEW GESCO SYSTEM WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585179 GESCO CATHETER, PERITONEAL DIALYSIS, SINGLE USE FOS UTAH MEDICAL PRODUCTS N/A 1130033

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DAY