BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3792671 · Received May 6, 2014

    Report

    Report Number
    1416980-2014-14553
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    LJH
    PMA / PMN Number
    K960787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER AND IS IN THE PROCESS OF BEING EVALUATED. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RECEIVED FOR EVALUATION WITH THE YELLOW TUBE AT THE END PULLED OFF AND THE CLEAR TUBING CRIMPED. THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. DURING FUNCTIONAL TESTING WATER WAS FLUSHED THROUGH THE DEVICE AND A SLOW FLOW OF FLUID WAS OBSERVED. THE REPORTED PROBLEM WAS NOT VERIFIED. THE CAUSE OF THE PROBLEM IS UNKNOWN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A Y-TYPE TUR IRRIGATION SET WOULD NOT FLOW DURING INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270322 ACCESS SYSTEM, IRRIGATION, UROLOGICAL LJH BAXTER HEALTHCARE R13C12178

    Patients

    Seq Age Sex Outcome Treatment
    1