BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 2931923 · Received January 28, 2013

    Report

    Report Number
    1416980-2013-02097
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE ACTUAL SAMPLE HAS BEEN MADE. SHOULD THE ACTUAL SAMPLE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS UNKNOWN, THEREFORE A BATCH REVIEW COULD NOT BE PERFORMED. AN EVALUATION OF THE ACTUAL SAMPLE WAS CONDUCTED. VISUAL INSPECTION, LEAK TESTING AND CLEAR PASSAGE TESTING WAS PERFORMED WITH NO ISSUES NOTED. FUNCTIONALLY HAND TIGHTENED A LAB TITANIUM ADAPTER TO SET WITH DIFFICULTY NOTED. SAMPLE WAS CONFIRMED FOR THE REPORTED PROBLEM. DIMENSIONAL INSPECTION OF THE RETURNED TRANSFER SET SAMPLE IDENTIFIED THAT THE INSIDE DIAMETER OF THE CATHETER ADAPTER SHROUD WAS NOT WITHIN SPECIFICATION LIMITS. IMPROVEMENTS WERE MADE TO THE MOLD AND MOLDING DEPARTMENT PROCEDURES. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CONNECTOR WAS NOT CONNECTED WITH THE TITANIUM ADAPTER WELL WHEN THE CUSTOMER CHANGED THE TRANSFER SET. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THERE WAS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37918 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOME CHOICE