BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3181381 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16098
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT REVEAL ANY NON-CONFORMITIES. THE DEVICE WAS TESTED UNDERWATER AND A LEAK WAS NOTICED FROM A SMALL SLIT UNDER THE Y-CONNECTOR. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD IV SOLUTION ADMINISTRATION SET WAS FULL OF AIR AND THE PRODUCT HAD LEAKED. THIS OCCURRED DURING USE. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO ADVERSE EVENT RELATED TO THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283232 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 13C31V813

    Patients

    Seq Age Sex Outcome Treatment
    1