BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3172417 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15506
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION IT WAS IDENTIFIED THAT THERE WAS NO STRONG BOND BETWEEN THE BLISTER AND THE BACKING PAPER. A CAUSE HAS BEEN NARROWED DOWN TO A MANUFACTURING ISSUE. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    DURING EVALUATION BY BAXTER PERSONNEL, IT WAS DETERMINED THAT A VIALMATE RECONSTITUTION DEVICE HAD DAMAGED PACKAGING. THE BACKING PAPER HAD DETACHED FROM THE BLISTER PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272821 IVT DISPOSABLE SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE 13B28VM02

    Patients

    Seq Age Sex Outcome Treatment
    1