BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2231826 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22155
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K101385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPANION SAMPLE WAS RETURNED FOR EVALUATION. DURING A VISUAL INSPECTION THERE WAS NO DEFECT OBSERVED. THE UNIT HAD A PRESSURE TEST AT 8 PSI AND THE RESULTS WERE SATISFACTORY. THE REPORTED CONDITION WAS NOT CONFIRMED AND THE CAUSE OF THE CONDITION WAS NOT IDENTIFIED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    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. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER (B)4) PORT A LEAK THAT OCCURRED AT THE CAP END OF A DUAL LUER LOCK CAP. THE CUSTOMER USES THIS PRODUCT AS AN END CAP FOR A LINE. THE PROCESS STEP WAS DURING PATIENT USE; THEREFORE, THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1