BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3781722 · Received April 30, 2014

    Report

    Report Number
    1416980-2014-14007
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 8, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K811078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS ANTICIPATED. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, AN UNUSED, SEALED DEVICE OF THE SAME LOT WAS RECEIVED. AN UNUSED, SEALED NON-BAXTER SET WAS ALSO RECEIVED. THE DEVICES WERE REMOVED FROM THEIR PACKAGING AND VISUALLY INSPECTED WITH NO ISSUES NOTED. EACH DEVICE'S LUER WAS THEN ISO GAUGED AND PASSED. THE TWO DEVICES WERE THEN CONNECTED, PRIMED, AND OBSERVED FOR LEAKAGE OR FLOW ISSUES; NO ISSUES WERE IDENTIFIED DURING THIS TEST. THE REPORTED CONDITION WAS UNABLE TO BE VERIFIED. 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

    A CUSTOMER REPORTED A LEAKING LUER-LOCK EXTENSION SET. THIS EVENT WAS REPORTED TO HAVE OCCURRED DURING PATIENT USE. ACCORDING TO THE REPORT, THE SET BEGAN LEAKING NEAR THE FEMALE LUER WHICH WAS CONNECTED TO A NON-BAXTER PRIMARY SET. THE USER DISCOVERED THE LEAK, DISCONNECTED AND RECONNECTED THE EXTENSION SET TO THE PRIMARY SET. FLUID CONTINUED TO LEAK OUT OF THE CONNECTION. THERE WAS PATIENT INVOLVEMENT, BUT NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259640 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R13H19164

    Patients

    Seq Age Sex Outcome Treatment
    1 NON-BAXTER PRIMARY ADMINISTRATION SET| ABBOTT PRIMARY IV SERIES A SET