BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3061970 · Received April 16, 2013

    Report

    Report Number
    1416980-2013-09431
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS WERE OBSERVED. LEAK TEST WAS CARRIED OUT UNDER WATER AT 8 PSI FOR MORE THAN 5 MINUTES, AND THERE WAS NO EVIDENCE OF A LEAK. THE REPORTED CONDITION WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A 1000 ML EVA PARENTERAL BAG WITH PEEL POUCH LEAKS. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162478 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - CALI SE12KC2

    Patients

    Seq Age Sex Outcome Treatment
    1