BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD SOLUTION ADMINISTRATIONSET

    MDR report key: 1982918 · Received February 9, 2011

    Report

    Report Number
    6000001-2011-00798
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 28, 2010
    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). AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, AND THE REPORTED CONDITION WAS NOT CONFIRMED. THERE WAS NO ISSUE RELATED TO LEAKAGE NOR BLOCKAGE WAS FOUND FROM THE ANALYSIS OF THE RETURNED SAMPLE; HENCE, THE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED ISSUE WAS NOT CONFIRMED ON THE UNIT RECEIVED FROM THE CUSTOMER. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, AN MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A BLOOD SOLUTION TRANSFER SET WITH A NOT FULLY INSERTED LUER LOCK THAT WAS NOTICED DURING THE PRIMING STEP. THERE WAS NO CLINICAL CONSEQUENCES REPORTED. NO PATIENT WAS INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD SOLUTION ADMINISTRATIONSET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10H08V339M

    Patients

    Seq Age Sex Outcome Treatment
    1