BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2210546 · Received August 12, 2011

    Report

    Report Number
    6000001-2011-18684
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 22, 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 CUSTOMER SENT IN SIX (6) COMPANION SAMPLES FOR AN EVALUATION. DURING VISUAL INSPECTION NO DEFECTS WERE OBSERVED. THE SIX UNITS RESULTS SATISFACTORY TO PRESSURE TEST AT 8PSI, AND TO A FUNCTIONAL TEST. THE REPORTED CONDITION WAS NOT CONFIRMED. THE CAUSE OF THE REPORTED CONDITION WAS NOT IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A DUAL LUER LOCK CAP IN WHICH THE UNIT FAILED TO FUNCTION. PRODUCT WAS USED AS AN END CAP FOR A LINE, THE LEAK OCCURED AT THE END CAP. THE PROBLEM HAS OCCURRED A FEW TIMES. 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 MEDICATION