BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECONSTITUTION DEVICE

    MDR report key: 1913203 · Received December 2, 2010

    Report

    Report Number
    6000001-2010-05410
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, AND THE REPORTED CONDITION WAS NOT CONFIRMED. THE SAMPLE WAS CONNECTED TO A VIAFLO BAG AND A VIAL; THEN RECONSTITUTION WAS PERFORMED. NO LEAKS WERE ENCOUNTERED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SAMPLE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS IS REPORT 2 OF 14 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, 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. THIS IS REPORT 14 OF 14 OF THE SAME REPORTED CONDITION FROM THIS FACILITY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A RECONSTITUTION DEVICE THAT LEAKED FLUID. THIS OCCURRED SEVERAL TIMES. HANDLING OF THE DEVICE WAS CHECKED AT THE CUSTOMER FACILITY AND DETERMINED IT WAS USED CORRECTLY. THERE IS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECONSTITUTION DEVICE SET, I.V. FLUID TRANSFER FRN BAXTER HEALTHCARE - MALTA 09F01V821

    Patients

    Seq Age Sex Outcome Treatment
    1