BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2210940 · Received August 12, 2011

    Report

    Report Number
    6000001-2011-18815
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K925126
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND 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.

    Description of Event or Problem · 1

    A DISTRIBUTOR CUSTOMER SERVICE REPRESENTATIVE (DCSR) CALLED BAXTER CORPORATE PRODUCT SURVEILLANCE (CPS) TO RELAY A REPORT FROM THEIR CUSTOMER OF FIVE (5) ALLEGED DEFICIENCIES FOR THE Y TYPE MICRO EXTENSION SET. EACH Y TYPE MICRO EXTENSION SET WAS "LEAKING AT THE Y" ON UNKNOWN DATE(S). THERE WAS NO PATIENT INVOLVEMENT OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS REPORTED. THIS IS REPORT 2 OF 5 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R11A26190

    Patients

    Seq Age Sex Outcome Treatment
    1