BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y-TYPE TUR-BLADDER IRRIGATIONSET

    MDR report key: 2013319 · Received March 10, 2011

    Report

    Report Number
    6000001-2011-01758
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 15, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    LJH
    PMA / PMN Number
    K960787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION ON 03/16/2011. A COMPANION SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE DID NOT REVEAL ANY ABNORMALITIES. THE SAMPLE WAS THEN SUBMITTED FOR A DIMENSIONAL TEST AND THE RESULTS WERE SATISFACTORY. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPANION SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER A Y-TYPE TUR-BLADDER IRRIGATION SET IN WHICH "IT DOESN'T STAY CONNECTED TO THE FOLEY CATHETER AND THEY HAVE TO TAPE IT." THE CONDITION OCCURRED DURING USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS IS REPORT 2 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Y-TYPE TUR-BLADDER IRRIGATIONSET SYSTEM, IRRIGATION, UROLOGICAL LJH BAXTER HEALTHCARE R10H27053

    Patients

    Seq Age Sex Outcome Treatment
    1 FOLEY CATHETER