BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTO/BLADDER IRRIGATION SET

    MDR report key: 1973087 · Received January 28, 2011

    Report

    Report Number
    6000001-2011-00469
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 25, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    LJH
    PMA / PMN Number
    K960787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION, AND A REQUEST HAS BEEN MADE FOR ITS RETURN. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). TWO COMPANION SAMPLES WERE RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED TO THE SETS AND THE RESULTS WERE SATISFACTORY; ALL COMPONENTS WERE PRESENT, IN THE RIGHT POSITION AND COMPLETE. THE SAMPLES WERE SUBMITTED FOR A PULL TEST; (5 LBS FOR 10 SEC) WAS APPLIED TO THE COMPONENTS BONDING ASSEMBLIES AND NO SEPARATIONS WERE OBSERVED. THE SAMPLES WERE THEN SUBMITTED FOR DIMENSIONAL TESTING AND THEY WERE WITHIN SPECIFICATIONS. THE REPORTED CONDITION WAS NOT CONFIRMED AND NO ROOT CAUSE WAS IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER A CYSTO/BLADDER IRRIGATION SET THAT SEPARATED. ACCORDING TO THE REPORT, THE LATEX SLEEVE DISCONNECTED FROM A KARL STORZ CYSTO INSTRUMENT/SCOPE. WHEN STAFF CONNECTS THE LATEX SLEEVE TO THE SCOPE AND THEY BEGIN FLUSHING WATER THROUGH THE LINE, THE SLEEVE SEPARATES FROM THE SCOPE. THE INCIDENT OCCURRED DURING USE IN SURGERY ON SEVERAL DIFFERENT OCCASIONS. THE EXACT AMOUNT OF OCCURRENCES IS UNKNOWN. 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
    1 CYSTO/BLADDER IRRIGATION SET SYSTEM, IRRIGATION, UROLOGICAL LJH BAXTER HEALTHCARE R10G22056

    Patients

    Seq Age Sex Outcome Treatment
    1 KARL STORZ CYSTO INSTRUMENT/SCOPE