BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS

    MDR report key: 2040464 · Received April 5, 2011

    Report

    Report Number
    6000001-2011-02589
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K003225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED ISSUE IS UNKNOWN. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. A LABELING REVIEW WAS PERFORMED AND IT WAS FOUND THAT IN THE NOTES SECTION OF THE DIRECTIONAL INSERT IT STATES THAT, (THIS PRODUCT DOES NOT CONTAIN NATURAL RUBBER LATEX). THE LABEL WAS FOUND TO CONTAIN THE APPROPRIATE DIRECTIONS, CAUTIONS AND NOTES. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A BAXTER SALES REPRESENTATIVE (BSR) REPORTED A PATIENT HAD AN ALLERGIC REACTION TO THE CLEARLINK EXTENSION SET. THE PATIENT'S SKIN WAS RED BENEATH WHERE THE EXTENSION SET WAS RESTING. PER THE BSR, THE PATIENT WAS ALLERGIC TO LATEX. IT IS UNKNOWN WHAT WAS INFUSING AT THE TIME OF THE REPORTED EVENT NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other