BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2895460 · Received January 3, 2013

    Report

    Report Number
    1416980-2013-00186
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 13, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: CONTACT WITH THE CUSTOMER WAS MADE ON (B)(6) 2013 AND THE FOLLOWING WAS REPORTED. THE NURSE STATED THAT THERE WAS A DISLODGMENT FROM THE WAY THEY SPIKED THAT BAG WHICH CAUSED THE LEAK. THE NURSE STATED THAT CLINICAL EDUCATORS HAD VISITED THEIR FACILITY AND THE PROBLEM HAS SINCE BEEN RESOLVED. THE NURSE DECLINED PROVIDING ANY ADDITIONAL INFORMATION. A BATCH REVIEW COULD NOT PERFORMED SINCE THE LOT NUMBER WAS NOT REPORTED. SINCE A SAMPLE WAS NOT AVAILABLE, THE REPORTED CONDITION COULD NOT BE CONFIRMED AND AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO THE CUSTOMER THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. IF THE SAMPLE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER CORPORATE SURVEILLANCE REGARDING A CLEARLINK SET WHICH HAD INSTANCES WHEN SPIKING PREMIX MED - AVELOX WHERE LEAKING WAS OBSERVED FROM THE TUBING AT THE SPIKE. THERE WAS NO PATIENT INVOLVEMENT, INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2497 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1