BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3192125 · Received June 27, 2013

    Report

    Report Number
    1416980-2013-16521
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION WAS PERFORMED, AND SEPARATED TUBING TO PATIENT CONNECTOR WAS NOTED. LEAK TESTING, CLEAR PASSAGE TEST, AND CLAMP FUNCTION TESTING WAS PERFORMED WITH NO ISSUES NOTED. THE SAMPLE WAS CONFIRMED FOR THE REPORTED PROBLEM. UPON COMPLETION OF BAXTER'S INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRANSFER SET DETACHED BETWEEN THE TRANSFER LINE AND THE 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
    293484 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 TITANIUM ADAPTER