BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTO/BLADDER IRRIGATION SET

    MDR report key: 1914852 · Received December 4, 2010

    Report

    Report Number
    6000001-2010-05526
    Event Type
    Malfunction
    Date Received
    December 4, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    LJH
    PMA / PMN Number
    K960787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 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. HOWEVER, A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE THAT ONE OF THEIR CUSTOMERS IS HAVING PROBLEMS WITH THE CYSTO/BLADDER IRRIGATION SET LEAKING WHEN IT IS CONNECTED TO THE PATIENT LINE. THE CONNECTION ON THE LAST 10 OF THEM HAD TO BE TAPED TO PREVENT LEAKAGE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE INCIDENT OCCURRED WITHIN THE LAST WEEK. THIS IS REPORT 1 OF 10 OF THE SAME REPORTED CONDITION FROM THIS CUSTOMER FACILITY. 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 R10E04132

    Patients

    Seq Age Sex Outcome Treatment
    1