BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 2223379 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11248
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 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). THIS COMPLAINT WAS CONFIRMED IN THE LAB FOR DIFFICULTY EXPERIENCED IN CONNECTING TO A CATHETER ADAPTER. THE PLANT EVALUATION DOES NOT INDICATE ANY VISIBLE IMPERFECTION OR RESIDUE ON THE PATIENT LUER, BUT CONFIRMED THE DIFFICULTY IN CONNECTION. THE SET, ONCE CONNECTED, DID PASS LEAK TESTING INDICATING FUNCTIONALITY. THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. 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.

    Description of Event or Problem · 1

    THIS IS AN INTERNATIONAL REPORT WHERE THE TRANSFER SET WAS NOT ABLE TO BE CONNECTED THE THE TITANIUM ADAPTER TIGHTLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THERE WAS PATIENT INVOLVEMENT.

    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 H11A24062

    Patients

    Seq Age Sex Outcome Treatment
    1