BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 3140438 · Received May 31, 2013

    Report

    Report Number
    1416980-2013-13928
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 7, 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). UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED. SAME EVENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE HOME PATIENT (HP) HAD CHANGED THE UV FLASH TRANSFER SET, THE PATIENT CONNECTOR OF THE TRANSFER SET DID NOT HAVE A GOOD CONNECTION WITH THE TITANIUM ADAPTER. 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
    242312 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ KANAE CO.,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 UV FLASH TRANSFER SET