BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3200747 · Received July 1, 2013

    Report

    Report Number
    1416980-2013-16973
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RECEIVED ONE UNUSED MINI-CAP TRANSFER SET FOR EVALUATION. VISUAL INSPECTION, LEAK TESTING AND CLEAR PASSAGE TESTS WERE PERFORMED WITH NO ISSUES NOTED. CLAMP FUNCTION TEST PERFORMED WITH NO ISSUES NOTED. PRESSURE TESTED THE SAMPLE WITH ACCEPTABLE RESULTS. FUNCTIONALLY HAND TIGHTENED A LAB TITANIUM ADAPTER TO SET WITH DIFFICULTY NOTED. DIMENSIONAL INSPECTION OF THE RETURNED TRANSFER SET IDENTIFIED THAT THE INSIDE DIAMETER OF THE CATHETER ADAPTER SHROUD WAS BELOW NOMINAL. THE SAMPLE WAS CONFIRMED FOR THE REPORTED CONDITION. IMPROVEMENTS WERE MADE TO THE MOLD AND MOLDING DEPARTMENT PROCEDURES. A REVIEW OF ALL BATCH RECORD DOCUMENTS LOT NUMBER H12J01053 WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF RETURNED COMPANION SAMPLES, A MINICAP TRANSFER SET WAS FOUND TO NOT MEET DIMENSIONAL SPECIFICATIONS. THIS SAMPLE HAD BEEN RETURNED UNOPENED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297761 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H12J01053

    Patients

    Seq Age Sex Outcome Treatment
    1