BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3041349 · Received April 8, 2013

    Report

    Report Number
    1416980-2013-08721
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR LOT NUMBER H11G25033 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. A VISUAL INSPECTION NOTED CRACKS IN THE TWIST CLAMP AS WELL AS ADDITIONAL CRACKS AND DETERIORATION OF THE SAMPLE. NO LEAK TEST OR CLAMP FUNCTION TEST COULD BE PERFORMED DUE TO THE DETERIORATION OF THE SAMPLE. CLEAR PASSAGE TESTING WAS PERFORMED WITH NO ISSUES NOTED. THE SAMPLE WAS CONFIRMED FOR DAMAGE. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER THAT THE TWIST CLAMP OF A TRANSFER SET WAS CRACKED. THE PATIENT USES BATH SOAP AND WATER TO CLEAN THE TRANSFER SET. THE SAMPLE WAS RECEIVED BY BAXTER, AND UPON EVALUATION, THE TRANSFER SET WAS FOUND TO HAVE ADDITIONAL, NONCOSMETIC DAMAGE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144093 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H11G25033

    Patients

    Seq Age Sex Outcome Treatment
    1