BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3231126 · Received June 26, 2013

    Report

    Report Number
    3231126
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    January 12, 2012
    Report Date
    July 4, 2012
    Manufacturer
    UNK
    Product Code
    DWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS BEING USED TO SUCTION BLOOD FROM THE PERICARDIUM. AS THE SURGEON MOVED THE LEVER TO THE ON POSITION TO START SUCTIONING, THE SCREW THAT HOLD THE LEVER TOGETHER ON THE DEVICE FELL OUT INTO THE PATIENT'S PERICARDIUM. THE SCREW WAS RETRIEVED BY THE SURGEON AND REMOVED FROM THE STERILE FIELD. NO PATIENT HARM. ANOTHER DEVICE WAS OBTAINED AND THE CASE CONTINUED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SUCTION TO REMOVE FLUID FROM THE OPERATIVE FIELD.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290657 * CONTROL TIP SUCTION DWM UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR