BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 LEAD TUR IRRIGATION SET

    MDR report key: 1810352 · Received August 20, 2010

    Report

    Report Number
    6000001-2010-02678
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    LJH
    PMA / PMN Number
    K960787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF LEAK WAS CONFIRMED. DURING THE VISUAL INSPECTION, IT WAS FOUND THAT THE Y-SITE WAS BROKEN. THE MOST PROBABLE CAUSE FOR THE LEAK CONDITION IS RELATED TO A BROKEN Y-SITE CAUSED DURING THE INJECTION MOLDING PROCESS. THE BATCH WAS MANUFACTURED WITH SATISFACTORY RESULTS (ZERO IN-PROCESS INSPECTION FAILURES). (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAKAGE OF THE SET NEAR THE CHAMBER DURING PRIMING. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 LEAD TUR IRRIGATION SET SYSTEM, IRRIGATION, UROLOGICAL LJH BAXTER HEALTHCARE - AIBONITO UR09E14084

    Patients

    Seq Age Sex Outcome Treatment
    1