BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3171239 · Received June 14, 2013

    Report

    Report Number
    1416980-2013-15453
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RECEIVED ONE UN-USED 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. 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 FOR POTENTIALLY ASSOCIATED LOT NUMBER H12D18059 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
    271602 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H12D18059

    Patients

    Seq Age Sex Outcome Treatment
    1