BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V. MUELLER HEMOSTAT

    MDR report key: 3893499 · Received June 11, 2014

    Report

    Report Number
    3893499
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 11, 2014
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    HRQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    DURING OPEN HEART SURGERY, ONE SIDE OF A HEMOSTAT JAW WAS FOUND TO BE BROKEN OFF AFTER USE IN THE PROCEDURE. AFTER A THOROUGH FIELD AND FLOOR SEARCH WERE CONDUCTED WITHOUT SUCCESS, RADIOLOGY WAS CALLED TO PERFORM FLUOROSCOPY. THE FOREIGN BODY WAS LOCATED AND REMOVED FROM THE PATIENT'S THORACIC CAVITY.THERE IS NO INFORMATION FOR THE MANUFACTURER-ADDRESS, AGE, SERIAL NUMBER, MODEL NUMBER AND LOT NUMBER. THE DEVICE IS AVAILABLE AT NCH FOR EVALUATION. THE MANUFACTURER HAS NOT BEEN MADE AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346273 V. MUELLER HEMOSTAT HEMOSTAT, SURGICAL HRQ CAREFUSION 2200, INC. UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR