BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2992162 · Received March 7, 2013

    Report

    Report Number
    1416980-2013-05462
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 15, 2013
    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). (B)(6). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE LIQUID HAD LEAKED OUT INTO THE BOX, SO FURTHER INVESTIGATION FOR THE REPORTED PARTICLE COULD NOT BE PERFORMED. THE REPORTED CONDITION WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT IDENTIFIED. 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

    THE CUSTOMER REPORTED TO BAXTER UNITED KINGDOM THAT A 250ML EVA BAG HAD FINE THREAD-LIKE FIBERS INSIDE THE BAG. THE CONDITION OCCURRED BEFORE USE. 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
    96661 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - MALTA 12B27V601

    Patients

    Seq Age Sex Outcome Treatment
    1