BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3932834 · Received July 14, 2014

    Report

    Report Number
    1416980-2014-22566
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    June 19, 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). (B)(6). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL EXAMINATION REVEALED THAT THE BAG HAD A TINY PARTICLE EMBEDDED IN THE BAG MATERIAL. THE PARTICLE DID NOT DETACH FROM THE BAG UPON BEING RUBBED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE AN ISSUE FROM AN EXTERNAL SUPPLIER. THE EXTERNAL SUPPLIER IS NO LONGER BEING UTILIZED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INFRARED SPECTROSCOPY SCAN WAS PERFORMED ON THE PARTICLE IN ORDER TO TRY AND ESTABLISH THE TYPE OF MATERIAL OF THE PARTICLE, BUT DUE TO THE VERY SMALL SIZE OF THE PARTICLE, THE SCAN RESULT WAS INCONCLUSIVE AND TYPE OF MATERIAL WAS NOT ESTABLISHED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ULTRASTAB BAG HAD PARTICULATE MATTER. THE REPORTER STATED THAT A PARTICLE APPEARS TO HAVE BEEN MOLDED IN THE MATERIAL OF THE BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410411 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - MALTA 13F14V902

    Patients

    Seq Age Sex Outcome Treatment
    1