BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3930322 · Received July 11, 2014

    Report

    Report Number
    1416980-2014-22461
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR FURTHER INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED WHICH IDENTIFIED A DAMAGED FEMALE CONNECTOR. LEAK TESTING WAS PERFORMED AND IDENTIFIED A LEAK BETWEEN THE CAP AND FEMALE CONNECTER, THEREFORE ALLOWING IODINE TO LEAK OUT FROM BETWEEN CAP AND CONNECTOR. CLEAR PASSAGE AND CLAMP FUNCTION TESTS WERE PERFORMED WITH NO ISSUES NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE WAS RECEIVED FOR EVALUATION AND THE EVALUATION IS IN PROCESS. UPON COMPLETION OF THE INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS DISCOVERED DURING EVALUATION OF A RETURNED TRANSFER SET THAT IT WAS LEAKING. THE DEVICE WAS RETURNED DUE TO EXCESS IODINE SOLUTION FOUND ON THE TRANSFER SET. THE PATIENT¿S CLOTHES WERE REPORTED TO HAVE GOTTEN IODINE ON THEM BECAUSE THERE WAS TOO MUCH IODINE. ONCE THE TRANSFER SET WAS CHANGED, THE PATIENT WAS NO LONGER EXPERIENCING THIS PROBLEM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405971 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 MINICAP