BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-FLOW

    MDR report key: 3870188 · Received June 4, 2014

    Report

    Report Number
    MW5036535
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 4, 2014
    Manufacturer
    I-FLOW LLC
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED REMOVAL OF ON-Q DUAL CATHETERS INTO AN ABDOMINAL INCISION THREE (3) DAYS POST-OPERATIVELY. RESISTANCE TO REMOVAL MET BILATERALLY. THE LEFT SIDE CATHETER WAS ADVANCED SLIGHTLY AND REMOVED WITHOUT DIFFICULTY. THE RIGHT SIDE CATHETER WAS ADVANCED SLIGHTLY AND WHILE REMOVING THE TUBING SNAPPED. ESTIMATE 2 1/4 INCHES REMAIN IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326788 I-FLOW ON-Q PAIN BUSTER MEB I-FLOW LLC PM025 0201054727

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other