BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3952504 · Received July 23, 2014

    Report

    Report Number
    1416980-2014-23830
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE BAG WAS RECEIVED FOR EVALUATION. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. A VISUAL INSPECTION AND FUNCTIONAL LEAK TESTING WERE PERFORMED, AND VERIFIED THE REPORTED ISSUE. THE LEAK WAS IDENTIFIED TO BE COMING FROM THE SEAL PORT. THE CAUSE OF THE LEAK WAS A MACHINE MALFUNCTION IN THE MANUFACTURING FACILITY. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EMPTY 3L EVA BAG LEAKED AT THE CONNECTION PORT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. 1 OF 3

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430653 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - CALI SE13AC1

    Patients

    Seq Age Sex Outcome Treatment
    1