BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 4210791 · Received October 29, 2014

    Report

    Report Number
    1416980-2014-37903
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 3, 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). THE DEVICE WAS RECEIVED FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL LEAK TESTING DETERMINED THAT THE DEVICE LEAKED BETWEEN THE WELDING OF THE ADDITIVE PORT TO THE BAG. CLOSER VISUAL EXAMINATION TO THE LEAK AREA REVEALED THAT THE BAG HAD A LACK OF WELDING. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE A MANUFACTURING ISSUE. TO ADDRESS THE ISSUE, A CAPA HAS BEEN OPENED AND THE PRODUCTION PROCEDURE WAS UPDATED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 2000ML MULTILAYER BAG WAS LEAKING. THIS WAS OBSERVED DURING THE FILLING PROCESS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693596 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - MALTA 14B10V553

    Patients

    Seq Age Sex Outcome Treatment
    1