BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2213644 · Received August 16, 2011

    Report

    Report Number
    6000001-2011-19228
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K981318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE USED SAMPLE AND 6 COMPANION SAMPLES FOR EVALUATION. THE SAMPLES WERE VISUALLY AND FUNCTIONALLY TESTED AND THE REPORTED CONDITION WAS NOT CONFIRMED. DURING VISUAL INSPECTION NO DEFECTS WERE OBSERVED. THE SEVEN UNITS PASSED THE PRESSURE TEST AT 8PSI AND FUNCTIONAL TESTING. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) REGARDING THE DUAL LUER LOCK CAP. THE PRODUCT IS USED AS A END CAP FOR A LINE AND A LEAK OCCURED AT THE CAP END. THE PROCESS STEP WAS DURING USE THEREFORE THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO 15302

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SET