BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2071231 · Received April 27, 2011

    Report

    Report Number
    6000001-2011-03243
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    LJH
    PMA / PMN Number
    K960787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE SAMPLE FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND THE REPORTED CONDITION WAS CONFIRMED, THE Y-SITE WAS SEPARATED FROM THE BURETTE BOTTOM CAP. IT WAS ALSO OBSERVED THAT THERE WAS AN INSUFFICIENT AMOUNT OF SOLVENT APPLIED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PATEINT REPORTED TO BAXTER (B)(4) OF A SEPARATION THAT OCCURRED BETWEEN THE TUBING AND CHAMBER DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS COMPLAINT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SYSTEM, IRRIGATION, UROLOGICAL LJH BAXTER HEALTHCARE - AIBONITO UR09A21211

    Patients

    Seq Age Sex Outcome Treatment
    1