BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 2190503 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10246
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S. THE DEVICE HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED SET WAS RECEIVED WITH ORIGINAL CAP ON SPIKE AND NO CAP ON PATIENT CONNECTOR IN REFERENCE TO CONNECTION ISSUE. THE SET WAS FUNCTIONALLY HAND TIGHTENED A LAB TITANIUM ADAPTER WITHOUT DIFFICULTY AND PRESSURE TESTED UNDERWATER WITH NO LEAK NOTED. DURING VISUAL INSPECTION NO ABNORMALITIES WERE NOTED. THE COMPLAINT COULD NEITHER BE CONFIRMED NOR DUPLICATED UNDER LAB CONDITIONS. A ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT THAT THE TITANIUM ADAPTER WAS DIFFICULT TO ATTACH TO THE CATHETER ADAPTER AND POSSIBLY THE TRANSFER SET. THE TITANIUM ADAPTER WAS NOT PRODUCED BY BAXTER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 TITANIUM ADAPTER