BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2936267 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02374
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K984381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE REGARDING AN UNKNOWN QUANTITY OF INTERLINK BURETROL SET(S) THAT 'CANNOT KEEP FLUID IN THE DRIP CHAMBER, THERE IS AIR IN THE CHAMBER DURING SETUP.' NO PATIENT INVOLVEMENT, INJURY OR ADVERSE EVENT IS REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40108 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR12I05162

    Patients

    Seq Age Sex Outcome Treatment
    1