BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3052123 · Received March 29, 2013

    Report

    Report Number
    3052123
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    TUBING BROKE OFF FROM BURETTE. BROKEN TUBING REMOVED AND REPLACED WITH A NEW TUBING KIT WITHOUT COMPLICATION. NO PATIENT HARM OCCURRED.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129632 * KIT, TUBING FPA BOSTON SCIENTIFIC MOO43521040 61258147

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR