BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 3180654 · Received June 20, 2013

    Report

    Report Number
    1416980-2013-16028
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    KANAE CO.,LTD.
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 INVOLVED IN THIS EVENT. THIS IS A REPORT OF A CONNECTION ISSUE WITH A LOCKING TITANIUM ADAPTER THAT WAS NOT CONNECTED WELL TO THE UV FLASH TRANSFER SET WHILE THE PATIENT WAS DOING THERAPY FOR PERITONEAL DIALYSIS. THE CAUSE OF THE CONNECTION ISSUE WAS UNKNOWN. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279835 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ KANAE CO.,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 UV FLASH TRANSFER SETS