BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEXITRON EQUIPO GRAV MACROGOT

    MDR report key: 1860760 · Received October 7, 2010

    Report

    Report Number
    6000001-2010-03852
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    July 19, 2010
    Report Date
    September 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - SAO PAULO
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE SAMPLE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION. A FOLLOW UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED AN ACTUAL SAMPLE FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED CONDITION WAS NOT CONFIRMED. A TEST WAS PERFORMED IN WHICH THE SET WAS ATTACHED TO A CATHETER AND THEN THE SET AND THE CATHETER WERE IMMERSED IN WATER, AND NO LEAKAGE POINT WAS IDENTIFIED. THE PRODUCTION AREA ALSO CONDUCTED A LEAK TEST ON THE SAMPLE RECEIVED AND THERE WAS NOT ANY LEAKAGES. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4)

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(4) OF A LEAK ON THE INJECTION SITE. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEXITRON EQUIPO GRAV MACROGOT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SAO PAULO PE28W0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION