BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 3223679 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18193
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    KANAE CO.,LTD.
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVENT INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE LOCKING TITANIUM ADAPTER WAS IDENTIFIED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. AS THE LOCKING TITANIUM ADAPTER WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 INVOLVED IN THIS EVENT. THIS IS A REPORT OF A PATIENT WHO WAS UNABLE TO SECURE A CONNECTION BETWEEN THE LOCKING TITANIUM ADAPTER AND THE MINICAP TRANSFER SET WHILE CHANGING THEIR TRANSFER SET FOR PERITONEAL DIALYSIS. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION INDICATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322909 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ KANAE CO.,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 MINICAP TRANSFER SET