BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3100484 · Received May 8, 2013

    Report

    Report Number
    1416980-2013-11728
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K921899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. ONE SAMPLE WAS RECEIVED FOR EVALUATION. THE SET WAS VISUALLY INSPECTED AND NO ISSUES OR DEFECTS WERE OBSERVED. FUNCTIONAL, PRESSURE, AND CLEAR PASSAGE TESTING WERE ALSO PERFORMED AND THE SET PASSED ALL TESTS AND FOUND TO FUNCTION AS INTENDED. THE REPORTED PROBLEM WAS NOT CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT AGE OF THE PATIENT IS UNKNOWN; HOWEVER, THEY WERE NOTED TO BE IN A CRIB AT THE TIME OF THE MALFUNCTION. THE EXACT OCCURRENCE DATE IS UNKNOWN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK T CONNECTOR DISCONNECTED FROM THE PATIENT DURING INFUSION OF AN UNKNOWN DRUG. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200763 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR13A08063

    Patients

    Seq Age Sex Outcome Treatment
    1