BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON-DEHP CL BURETROL (BALL VALVE DRIP CHMBR) SET W/2YS 60DPM

    MDR report key: 2060224 · Received April 15, 2011

    Report

    Report Number
    6000001-2011-02909
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K984381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS AVAILABLE FOR EVALUATION; HOWEVER, THE SAMPLE HAS NOT YET BEEN RECEIVED. ONCE THE SAMPLE IS RECEIVED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS SENT IN FOR AN EVALUATION. DURING A VISUAL INSPECTION, IT WAS OBSERVED OF A CRACKED/BROKEN BURETTE. THE PRESSURE TEST WAS PERFORMED AT 8 PSI TO THE BURETTE AND THE BURETTE DOES NOT LEAK. BY THIS RESULT THE DEFECT IS RELATED TO A GEL MARK IN THE BURETTE. THEREFORE, THE CUSTOMER REPORTED CONDITION WAS CONFIRMED; THE CAUSE FOR THIS CONDITION IS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER PRODUCT SURVEILLANCE OF AN UNSPECIFIED BURETROL IV TUBING SET IN WHICH THERE IS A SLIT NOTICED ON THE DRIP CHAMBER WHICH WAS DISCOVERED PRIOR TO USAGE. NO PATIENT INVOLVEMENT, INJURY OR ADVERSE EVENT IS REPORTED. THERE IS NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON-DEHP CL BURETROL (BALL VALVE DRIP CHMBR) SET W/2YS 60DPM SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1