BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3071578 · Received April 22, 2013

    Report

    Report Number
    1416980-2013-10037
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PARTICULATE MATTER FOUND DURING SAMPLE EVALUATION WAS CONFIRMED. THE CAUSE WAS UNDETERMINED. IF ADDITIONAL INFORMATION IS OBTAINED, THEN A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING THE SAMPLE EVALUATION OF A RETURNED TRANSFER SET, THERE WAS PARTICULATE MATTER DISCOVERED IN THE SET. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED WITH THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172952 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1