BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3942093 · Received July 17, 2014

    Report

    Report Number
    1416980-2014-23040
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION A PARTICLE WAS OBSERVED WITHIN THE BAG. THE PARTICLE WAS NOTED IN THE SOLUTION WITH MICROSCOPIC INSPECTION. FOURIER TRANSFORM INFRARED SPECTROSCOPY DETERMINED THE PARTICLE TO BE ACRYLONITRILE BUTADIENE STYRENE (ABS) MATERIAL. THE REPORTED PROBLEM WAS VERIFIED. THE MANUFACTURING FACILITY USES ABS MATERIAL TO PRODUCE COMPONENTS OF THIS PRODUCT. A CAPA HAS BEEN OPENED FOR THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WILL BE PERFORMED. IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PARTICULATE MATTER WAS FOUND INSIDE OF A 250 ML EVA BAG. THERE WAS NO PATIENT INVOLVEMENT AS THIS WAS IDENTIFIED BEFORE PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418777 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - MALTA 14B01V495

    Patients

    Seq Age Sex Outcome Treatment
    1