BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3111030 · Received May 14, 2013

    Report

    Report Number
    1416980-2013-12245
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS VISUALLY INSPECTED, AND IT WAS NOTED THAT THERE WAS DAMAGE TO THE THREADS OF THE DARK BLUE CONNECTOR. LEAK TESTING NOTED A LEAK COMING FROM BETWEEN THE CAP AND BLUE CONNECTOR. CLEAR PASSAGE AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE SAMPLE CONFIRMED THE LEAK. THE CAUSE OF THE LEAK WAS THE DAMAGED THREADS, BUT THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A TRANSFER SET, A LEAK WAS NOTED COMING FROM BETWEEN THE CAP AND THE BLUE CONNECTOR. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212550 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1