BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 2161354 · Received July 13, 2011

    Report

    Report Number
    1423500-2011-09010
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 10, 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). RECEIVED ONE USED SET WITH CAP ON SPIKE AND NO CAP ON PATIENT CONNECTOR IN REFERENCE TO THE ISSUE OF "TOO TIGHT TO CLOSE AND OPEN". THE RETURNED CLAMP WAS EXAMINED HAD A HIGHER CLOSING FORCE THAN NORMAL. THE REPORTED ISSUE WAS CONFIRMED BY TORQUE TESTING WHICH SHOWED HIGHER FORCES REQUIRED THAN A CONTROL PART. THE ROOT CAUSE IS UNDETERMINED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE SLEEVE OF THE SET WAS TOO TIGHT TO CLOSE AND OPEN. NO SOLUTION WAS ATTACHED TO THE TRANSFER SET. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE ACTUAL SAMPLE IS AVAILABLE FOR EVALUATION.

    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