BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 6031737 · Received October 14, 2016

    Report

    Report Number
    1416980-2016-16281
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 30, 2016
    Report Date
    December 20, 2016
    Manufacturer
    KANAE CO. LTD., CHOU-KU
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: EVALUATION CODES WERE ADDED. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CUSTOMER CHANGED THE TRANSFER SET THE PATIENT ADAPTOR WAS NOT CONNECTED WITH THE TITANIUM ADAPTOR WELL. THIS EVENT OCCURRED DURING USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681856 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ KANAE CO. LTD., CHOU-KU NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 LUER TRANSFER SET