BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2933766 · Received January 29, 2013

    Report

    Report Number
    1416980-2013-02190
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A SAMPLE EVALUATION WAS PERFORMED. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. LEAK TESTING WAS PERFORMED WITH NO ISSUES NOTED. A CLEAR PASSAGE TEST AND CLAMP FUNCTION TEST WERE PERFORMED WITH NO ISSUES NOTED. A BATCH REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE SAMPLE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A DOCTOR CONTACTED BAXTER (B)(4) REGARDING A CONNECTION ISSUE WITH A MINICAP TRANSFER SET. THE DOCTOR STATED THAT THE FEMALE CONNECTOR OF THE TRANSFER SET WAS NOT CONNECTED WITH THE MINICAP WELL. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39626 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 MINICAP