BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3900565 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20704
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 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). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. A BATCH REVIEW WILL BE PERFORMED. IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND FOUND NO NON-CONFORMANCES. AN UNDER-WATER LEAK TEST IDENTIFIED A LEAK FROM BETWEEN THE BAG AND THE INFUSION PORT. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE CAUSE WAS DETERMINED TO BE A SLIGHT LACK OF WELDING. IT IS TO BE STATED THAT THIS BAG IS 100% LEAK TESTED AT THE MANUFACTURING PLANT IN ORDER TO DETECT SUCH ISSUES. IN SUCH CASES IT IS POSSIBLE THAT THE BAG DIDN¿T LEAK DURING THE LEAK TEST AT THE PLANT BUT LEAKED AT THE CUSTOMER SITE AFTER HANDLING/PACKING/TRANSPORTATION/USE OF THIS INVOLVED SET, HOWEVER THIS CANNOT BE VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ULTRASTAB 2L BAG WITH 4 LEADS LEAKED FROM THE PORT OF ITS BAG. THIS OCCURRED DURING STORAGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378084 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - MALTA 14B10V553

    Patients

    Seq Age Sex Outcome Treatment
    1