BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSFER SET MINICAP INTEGRALTWIST CLAMP

    MDR report key: 1955306 · Received January 10, 2011

    Report

    Report Number
    1423500-2011-00372
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    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. ADDITIONAL INFORMATION: THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS INCIDENT. THIS REPORT OF A LEAK IN THE TRANSFER SET WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS NOT DETERMINED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION EXPECTED, BUT NOT YET COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A LEAK AT THE TWIST CLAMP OF A TRANSFER SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSFER SET MINICAP INTEGRALTWIST CLAMP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H10B16042

    Patients

    Seq Age Sex Outcome Treatment
    1