BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y-TYPE TUR IRRIGATION SET

    MDR report key: 1844089 · Received September 24, 2010

    Report

    Report Number
    6000001-2010-03508
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    BAXTER HEALTHCARE
    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

    (B)(4). CORRECTION. PRODUCT CODE: LJH. COMMON DEVICE NAME: SYSTEM, IRRIGATION, UROLOGICAL. ADDITIONAL INFORMATION. THE SAMPLE WAS RECEIVED FOR EVALUATION ON (B)(4) 2010. AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION FOR THE REPORTED CONDITION OF A LEAK. A VISUAL EXAMINATION WAS PERFORMED ON THE SAMPLE AND FOUND NO ABNORMALITIES. THE SAMPLE WAS THEN SUBMITTED FOR AN UNDERWATER PRESSURE TEST IN WHICH A LEAK WAS OBSERVED CAUSED BY A HOLE IN THE Y-JUNCTION SITE. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE ROOT CAUSE OF THIS CONDITION IS ATTRIBUTED TO A MANUFACTURING ISSUE.

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED IF THE SAMPLE IS RETURNED AND EVALUATED OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) ON (B)(6), 2010 AN INCIDENT WHERE THE SET WAS LEAKING WHILE IN USE WITH THE Y-TYPE IRRIGATION SET. THIS INCIDENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Y-TYPE TUR IRRIGATION SET SYSTEM, IRRIGATION, UROLOGICAL LJH BAXTER HEALTHCARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1