BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2411692 · Received January 11, 2012

    Report

    Report Number
    6000001-2012-02234
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    December 19, 2011
    Report Date
    December 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    LJH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. 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). THREE COMPANION SAMPLES WERE RETURNED TO THE MANUFACTURING PLANT FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE OBSERVED. THE SETS WERE TESTED FOR GRAVITY AND THEN FOR LEAKAGE AT 0.56 BAR; NO ISSUE WAS OBSERVED. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) A UROMATIC EASY FLOW UNI-SET IN WHICH A LEAK WAS OBSERVED FROM AN UNKNOWN LOCATION. THE ALLEGED DEFECT WAS OBSERVED AFTER THE SET WAS ATTACHED TO THE SOLUTION BAG, BUT BEFORE PATIENT ATTACHMENT. THEREFORE, THERE WERE NO REPORTS OF PATIENT INVOLVEMENT, PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENTS ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SYSTEM, IRRIGATION, UROLOGICAL LJH BAXTER HEALTHCARE - MALTA 11F08V757

    Patients

    Seq Age Sex Outcome Treatment
    1