BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL SYSTEM CATHETER EXT SET/LUER ACTIVATED VALVE FOR IV ACCES

    MDR report key: 1941561 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06374
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K003225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION PURPOSES RELATED TO NO FLOW/RESTRICTED FLOW CONDITION. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, AND THE REPORTED CONDITION WAS CONFIRMED. THE UNIT HAD CLEAR PASSAGE, PRESSURE TESTED AT 8 PSI, AND WAS FUNCTIONALLY TESTED. BLOCK CONDITION WAS CONFIRMED BETWEEN THE MALE LUER LOCK AND TUBING. IT IS UNKNOWN WHAT MAY HAVE CAUSED THIS REPORTED CONDITION. A BATCH REVIEW WAS CONDUCTED, AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN RECEIVED AND IS AVAILABLE FOR EVALUATION. ONCE THE SAMPLE HAS BEEN EVALUATED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SAMPLE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO A BAXTER SALES REPRESENTATIVE OF A CATHETER EXTENSION SET THAT WOULD NOT FLOW WHEN IT WAS BEING FLUSHED. THIS INCIDENT OCCURRED DURING PATIENT USE. 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 CL SYSTEM CATHETER EXT SET/LUER ACTIVATED VALVE FOR IV ACCES SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR10G07032

    Patients

    Seq Age Sex Outcome Treatment
    1 SYRINGE