BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3498926 · Received October 16, 2013

    Report

    Report Number
    3008355164-2013-00267
    Event Type
    Malfunction
    Date Received
    October 16, 2013
    Date of Event
    September 18, 2013
    Report Date
    September 20, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE EDI CATHETER WAS REMOVED AFTER 2 DAYS OF USE, A PIN HOLE WAS NOTICED AT THE 20 CM MARK WHEN THE EDI CATHETER WAS FLUSHED WITH SALINE. THE EDI CATHETER WAS NOT USED FOR FEEDING. THE FACILITY STATED THAT NO SHARP OBJECTS (SCISSORS, PINS) WERE NEAR THE TUBE. THERE WAS NO PT HARM.(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530962 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR