BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK SYSTEM EXT SET .22MICRON FILTER LUER ACT VALVE

    MDR report key: 1914869 · Received December 4, 2010

    Report

    Report Number
    6000001-2010-05542
    Event Type
    Malfunction
    Date Received
    December 4, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K964850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE ACTUAL SAMPLE FOR EVALUATION. THE SAMPLE WAS VISUALLY AND FUNCTIONALLY TESTED AND THE REPORTED CONDITION WAS CONFIRMED. THE TUBING WAS OBSERVED TO BE SEPARATED FROM THE Y-SITE. PRESENCE OF SOLVENT WAS OBSERVED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. 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. AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CLEARLINK EXTENSION SET, WITH 0.22 MICRON FILTER, WHICH SEPARATED DURING PRIMING. THE CONDITION OCCURRED IN THE FACILITY'S ONCOLOGY/HEMATOLOGY DEPARTMENT. IT IS UNKNOWN WHAT MEDICATION WAS BEING USED AND IT IS UNKNOWN WHERE ON THE SET THE SEPARATION OCCURRED. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK SYSTEM EXT SET .22MICRON FILTER LUER ACT VALVE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1