BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 4843839 · Received June 15, 2015

    Report

    Report Number
    1416980-2015-25212
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 29, 2015
    Report Date
    May 29, 2015
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION, PARTICULATE MATTER WAS OBSERVED WITHIN THE FLUID PATHWAY OF THE DEVICE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A HAIR IN AN INTRAVIA EMPTY CONTAINER. THIS WAS NOTED WHILE THE DEVICE WAS BEING FILLED WITH SALINE SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387745 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR15B19041

    Patients

    Seq Age Sex Outcome Treatment
    1