BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3851614 · Received June 5, 2014

    Report

    Report Number
    1416980-2014-18008
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE USED DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THERE WERE BUBBLES IN THE SOLUTION OF THE DEVICE; HOWEVER, NO PARTICULATE MATTER WAS OBSERVED. THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. 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 OBSERVED INSIDE OF AN INTRIVIA CONTAINER. THIS MALFUNCTION WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329389 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR13J30051

    Patients

    Seq Age Sex Outcome Treatment
    1