BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2230051 · Received August 31, 2011

    Report

    Report Number
    6000001-2011-21875
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    July 23, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED 6 COMPANION SAMPLES FOR EVALUATION. THE SAMPLES WERE VISUALLY AND FUNCTIONALLY TESTED AND THE REPORTED CONDITION WAS NOT CONFIRMED. THE RETURNED SAMPLES WERE TESTED FOR GRAVITY AND THEN FOR LEAKAGE AT (B)(4), AND ALL SIX PASSED. AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER FRANCE REGARDING THE STANDARD 118 Y SET IN WHICH A LEAK OCCURRED DURING PATIENT USE ON (B)(6) 2011 THERE IS NO OTHER INFORMATION AVAILBLE ACCORDING TO THE REPORTER. THE REPORTER STATED THAT THERE IS NO CLINICAL CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10K12V417M

    Patients

    Seq Age Sex Outcome Treatment
    1