BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2902117 · Received January 8, 2013

    Report

    Report Number
    1416980-2013-00523
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K921899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS REPORT FOR AS REPORTED PROBLEM CODE LEAKS - SEPARATED COULD NOT BE CONFIRMED AND/OR A CAUSE IDENTIFIED THROUGH SAMPLE EVALUATION. SAMPLE EVALUATION IS AS FOLLOWS: NINETY THREE (93) UNUSED SAMPLES WERE RECEIVED FOR EVALUATION. THE SAMPLES WERE VISUALLY AND FUNCTIONALLY TESTED. NO DEFECTS WERE FOUND DURING VISUAL INSPECTION AND ALL SETS WERE FOUND TO FUNCTION AS DESIGNED. BATCH INFORMATION WAS REVIEWED AND NO ISSUE OR DEVIATIONS WERE NOTED DURING THE MANUFACTURING OF THIS LOT. IF ANY ADDITIONAL INFORMATION IS AVAILABLE A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED A BAXTER SALES REPRESENTATIVE TO REPORT AN UNKNOWN NUMBER OF INTERLINK T-CON EXT SET/MICRO-BORE (B)(4) EXTENSION SETS IN WHICH A LEAK WAS OBSERVED. ACCORDING TO THE REPORT, THE NURSING UNIT STATED THAT "THEY ARE LEAKING BETWEEN THE TUBING AND THE HUB." THERE WAS NO INDICATION OF A PATIENT INJURY OR ADVERSE EVENT TO BE IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8887 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1