BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2895440 · Received January 3, 2013

    Report

    Report Number
    1416980-2013-00184
    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). A BATCH REVIEW COULD NOT PERFORMED SINCE THE LOT NUMBER WAS NOT REPORTED. THE COMPLAINT IS NOT CONFIRMED AND THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER HAD CONTACTED BAXTER CORPORATE SURVEILLANCE REGARDING A CLEARLINK SET THAT HAD A ROLLER CLAMP PINCH THE IV TUBING AND CAUSE A TEAR. 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
    2094 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1