BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3942298 · Received July 17, 2014

    Report

    Report Number
    1416980-2014-23077
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 23, 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). (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED. A VISUAL INSPECTION WAS PERFORMED WITH THE EYE AND USING THE MICROSCOPE AND ONLY AN UNRELATED ISSUE NOTED (ADDRESSED IN (B)(4)). A LEAK TEST AND CLEAR PASSAGE TEST WERE PERFORMED WITH NO ISSUES NOTED. A CLAMP FUNCTION TEST WAS PERFORMED WITH NO ISSUES NOTED. AN INTEGRITY OF SEAL TEST WAS PERFORMED WITH NO ISSUES NOTED. THE REPORTED PROBLEM COULD NOT BE IDENTIFIED OR DUPLICATED DURING THE EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINICAP TRANSFER SET WOULD NOT CONNECT PROPERLY. THIS OCCURRED BEFORE USE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418914 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1