BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3240226 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19269
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 1, 2013
    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). VISUAL INSPECTION, LEAK TESTING, CLEAR PASSAGE TESTING, AND CLAMP FUNCTION TESTING WERE PERFORMED ON THE DEVICE WITH NO ISSUES NOTED. THE INTEGRITY OF THE SEAL SURFACE WAS TESTED AND NO LEAKS WERE FOUND. THE INSIDE DIAMETER OF THE PATIENT CONNECTOR WAS MEASURED AND FOUND TO BE BELOW NOMINAL. THEREFORE, INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT EVALUATION HAS NOT YET BEGUN. SHOULD THE DEVICE BE RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE WAS DETERMINED TO BE A MANUFACTURING ISSUE. IMPROVEMENTS WERE MADE TO THE MOLD AND MOLDING DEPARTMENT PROCEDURES TO ADDRESS THIS ISSUE. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONNECTOR OF THE MINICAP TRANSFER SET SEPARATED FROM A NON-BAXTER TITANIUM ADAPTER. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341116 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 NON-BAXTER TITANIUM ADAPTER