BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2082250 · Received May 9, 2011

    Report

    Report Number
    1423500-2011-05646
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 SAMPLE 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 CAP ON DARK BLUE CONNECTOR AND NO CAP ON PATIENT CONNECTOR IN REFERENCE TO LEAK. THE SET WAS FUNCTIONALLY HAND TIGHTENED TO A LAB TITANIUM ADAPTER WITHOUT DIFFICULTY AND WAS PRESSURE TESTED UNDERWATER WITH NO LEAK NOTED. DURING VISUAL INSPECTION THE PATIENT CONNECTOR AND BUSHING CONTAINED A BLUE/GRAY DISCOLORATION. THE COMPLAINT COULD NEITHER BE CONFIRMED NOR DUPLICATED UNDER LAB CONDITIONS WITH THE RETURNED SAMPLE. THEREFORE, THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. THE RETURNED SAMPLE RETURNED DID NOT SHOW ANY CONNECTION PROBLEM OR LEAKAGE. 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 LEAKAGE WAS FOUND FROM THE CONNECTION BETWEEN THE PATIENT CONNECTOR AND THE CATHETER ADAPTER. THE SET HAD BEEN USED FOR 60 DAYS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 TITANIUM ADAPTOR